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The Committee for Veterinary Medicinal Products (CVMP) recently finished its conference, which focused on enhancing animal health and welfare from July 11 to 13, 2023.…

In response to an ongoing review, the European Medicines Agency (EMA) has issued a statement regarding GLP-1 receptor agonists. These medications are commonly used in…

The European Medicines Agency (EMA) recently issued an essay outlining the main points of the Pharmacovigilance Risk Assessment Committee (PRAC) conference, which took place from…

The European Medicines Agency (EMA) has officially declared the gradual discontinuation of exceptional regulatory flexibilities that were put in place during the COVID-19 pandemic. These…

The European Medicines Agency (EMA) has released a review highlighting the use of real-world evidence (RWE) in regulatory decision-making. Real-world evidence refers to data collected…

The Federal Institute for Drugs and Medical Devices (BfArM) has released important information regarding the pharmacovigilance of Voxzogo® (vosoritide). The latest update pertains to a…

The European Medicines Agency (EMA) has released a workshop report outlining recommendations to enhance clinical trials during public health emergencies in the EU. The report…

Youth-led campaigns have been instrumental in finding fresh and innovative ways to communicate about public health issues. These campaigns have the ability to make complex…

In a proactive response to the increasing number of hospital admissions attributed to anaphylactic reactions, the Medicines and Healthcare products Regulatory Agency (MHRA) has reinforced…

Exciting news in healthcare innovation! The FDA has granted clearance to the groundbreaking V-PRO maX 2 Low Temperature Sterilization System. This cutting-edge system is a…

Abu Dhabi Global Healthcare Week is set to be held from May 13-15, 2024, at the Abu Dhabi National Exhibition Centre. Organized by the Department…

The Dubai Health Authority (DHA) successfully concluded its summer training program for Emirati students. The program aimed to provide students with valuable practical experience and…

The Gulf Health Council has launched an educational guide titled "Antimicrobial Resistance." This guide addresses the significant health issue of antimicrobial resistance, aiming to raise…

In a recent assessment, the European Medicines Agency (EMA) investigated the impact of paternal exposure to Valproate, a medication used for epilepsy and bipolar disorder.…

A groundbreaking advancement in the fight against polio has emerged, offering the potential to cut detection times in half. Recent research, as highlighted by the…

The UK government has announced a monumental commitment of £210 million to address one of the most pressing global health threats: antimicrobial resistance (AMR).  The…

The Department of Health – Abu Dhabi (DoH) has closed a medical laboratory in the Emirate for violating regulations. The laboratory, which is located in…

The European Medicines Agency (EMA) is taking proactive steps to safeguard the health of expectant mothers and their unborn children by recommending new measures to…

In a progressive move towards safeguarding the public's health and interests, the UK government has officially commenced a consultation on unregulated cosmetic procedures. This significant…

We would like to bring to your attention an important recall notice regarding certain products manufactured by Sun Pharma UK Ltd. Specifically, this alert pertains…

We would like to bring to your attention an important recall notice regarding Ketofall 0.25 mg/ml Eye Drops Solution in single-dose containers.   Background Information:…

  Advancements in Device Safety Communication:    The FDA's Center for Devices and Radiological Health (CDRH) has released a comprehensive report to Congress on Postmarket Device…

Introduction: In a move to ensure the safety and efficacy of weight management medications, the European Medicines Agency (EMA) has recently launched a comprehensive review…

We want to bring to your attention an urgent recall affecting two specific batches of Lipocomb capsules, Lipocomb 10 mg/10 mg (batch PPA0465/460/001) and Lipocomb…

In a critical advisory, healthcare professionals are being urged to exercise utmost caution when prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin). This class of…

Dear Healthcare Providers, We are writing to inform you of an important safety notice regarding Terumo Platelet Additive Solution+ (T-PAS+). Please carefully review the following…

In a recent development, the European Medicines Agency's (EMA) human medicines committee (CHMP) has recommended against renewing the conditional marketing authorization for Blenrep (belantamab mafodotin),…

Introducing the Vaccine Monitoring Platform (VMP) research agenda The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) have introduced…

 The U.S. Food and Drug Administration (FDA) has taken a monumental step towards combating rare diseases. In a recent announcement, the agency disclosed the allocation…

The Pharmacovigilance Risk Assessment Committee (PRAC) convened from September 25th to 28th, 2023, to review critical safety data. Among the significant outcomes was the decision…

In a recent update, the Medicines and Healthcare products Regulatory Agency (MHRA) has released important information regarding statins and their potential link to myasthenia gravis.…

Today, the U.S. Food and Drug Administration announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific…

In a significant development, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended against renewing the marketing authorization for…

In a groundbreaking stride towards revolutionizing the field of stem cell therapy, the Head of the Medicines and Healthcare products Regulatory Agency’s UK Stem Cell…

Pseudoephedrine is licensed for the symptomatic relief of nasal and sinus congestion in colds, flu, and allergies. It has been used in the UK for…

MHRA approved the Rubidium (Rb82) Generator (RUBY-FILL) as a diagnostic tool for imaging of the heart to aid in the diagnosis of suspected or known…

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have launched new lists that show where scientists can find real-world data and…

EMA’s safety committee (PRAC) concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of postmenopausal…

Today, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver…

FDA Warns Consumers about Potential for Dangerous Health Effects that can result from Certain Topical Pain Relief Products The U.S. Food and Drug Administration is…

New combined antibiotic approved to treat adult patients with severe infections of the urinary tract and hospital-acquired pneumonia   The Medicines and Healthcare products Regulatory…

TGA Updated warnings of faricimab (Vabysmo) retinal vasculitis risk Faricimab is indicated for: Neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO) Faricimab…

PRAC committee latest meeting doesn’t support a causal association between the Glucagon-Like Peptide-1 receptor agonists (GLP-1) and suicidal and self-injurious thoughts and actions   The PRAC has…

FDA Approves New Antimicrobial Drug for Cattle and Swine   Today, the U.S. Food and Drug Administration approved Pradalex (pradofloxacin injection) solution for certain respiratory…

ETF recommends updating COVID-19 vaccines to target new JN.1 variant Updated vaccines will help maintain protection against disease as virus continues to evolve, MA’s Emergency Task…

FDA Approves New Treatment for Uncomplicated Urinary Tract Infections Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female…

The MHRA will introduce a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects, MHRA is asking…

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (3 May 2024) approved two new formulations of the medicine cabotegravir (Apretude 30 mg film-coated…

New boxed warnings are being added to the patient information leaflets (PIL) of montelukast due to neuropsychiatric reactions as a result of MHRA review More prominent…

Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024 meeting-Hydroxyprogesterone caproate medicines to be suspended from the EU market EMA’s safety committee (PRAC) has recommended…

The Product Information (PI) documents for all selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) have been aligned to reflect the…

An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients,…

The U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved…

Topical steroid products are safe and highly effective treatments for the management of a wide range of inflammatory skin diseases but have important risks, especially…

EMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and older…

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe haemophilia B in adults…

Pilots are part of ACT EU collaboration to foster high-quality clinical research in the EU. The Accelerating Clinical Trials in the EU (ACT EU) initiative is today…

Today, the U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD)…

Taking warfarin and tramadol together can cause harmful drug interactions, which can raise the International Normalized Ratio (INR), and result in severe bruising and bleeding,…

EMA’s human medicines committee (CHMP) has concluded its review of the medicine Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorisation be revoked, because its…

EMA has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other…

Eurneffy (epinephrine) is an alternative to injectable formulations, EMA’s human medicines committee (CHMP) has recommended granting a marketing authorization in the European Union for Eurneffy (epinephrine), the…

Migraine and antiseizure medication topiramate must no longer be prescribed to women and girls unless they fulfil the requirements of a Pregnancy Prevention Programme. Following a…

Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C…

The TGA has received reports of serious adverse events in infants and children who have been given compounded wind and colic preparations containing Atropa belladonna (belladonna). We…

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new formulation of the medicine ocrelizumab (Ocrevus 920mg solution for injection) to treat relapsing…

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine capivasertib (Truqap) for patients with advanced hormone receptor (HR)…

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine vibegron (Obgemsa) to treat the symptoms of overactive bladder…

Epimax Ointment and Epimax Paraffin-Free Ointment can harm the eyes if used on the face. Do not prescribe these ointments for use on the face.…

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first generic raltegravir medicines to treat adult and paediatric HIV patients who weigh at…

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for semaglutide (Wegovy) to reduce the risk of overweight and obese adults…

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an adapted Pfizer/BioNTech COVID-19 vaccine (Comirnaty) that targets the JN.1 COVID-19 subvariant.   This vaccine…

The U.S. Food and Drug Administration approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma…

The U.S. Food and Drug Administration approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and…

Validating processes is an important step towards establishment of African Medicines Agency, EMA has awarded a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative…

First Home Antibody Test Can Inform Patients of Current or Past Infection and Lead to Confirmatory Testing with Health Care Provider, The U.S. Food and…

A new targeted cancer treatment, given in combination with a standard chemotherapy, for adults with stomach (gastric) or gastro-oesophageal junction cancer has been approved by…

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a product license for the medicine lecanemab (Leqembi) for use in the early stages of…

The U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, Agency Supports Broader Access to Innovative Technology in Diabetes Management, an…

Guiding principles set out how EU medicine regulators can use LLMs in a safe, responsible and effective manner, EMA and the Heads of Medicines Agencies (HMA) have…

The U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants…

EMA’s safety committee, PRAC, has recommended measures to minimize the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole. Agranulocytosis involves a…

Following a thorough review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that the available evidence does not establish a causal relationship between…

MHRA launches a new strategy aims to transform the way we provide information on the risks and safety of medicines and medical devices. The Medicines…

The European Medicines Agency (EMA) has suggested expanding the use of the Imvanex smallpox and mpox vaccine to adolescents between the ages of 12 and…

The U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type C (NPC). Miplyffa, in combination with the…

The U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is authorized for the prevention of influenza in those ages 2 to 49 who…

The Medicines and Healthcare products Regulatory Agency (MHRA) approved the new medicine fruquintinib (Fruzaqla) to care for adult patients who have colorectal cancer that has…

EMA’s human medicines committee (CHMP) has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta (voxelotor); this measure is taken as a…

Cobenfy (xanomeline and trospium chloride) capsules have been approved by the US Food and Drug Administration for oral use in the treatment of adult schizophrenia.…

Steps to maximize the utilization of EU's specialized resources for expedited evaluations, working together, the European Medicines Agency (EMA) and the European Medicines Regulatory Network…

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved leniolisib phosphate (Joenja) to treat a rare immune disease known as activated phosphoinositide 3-kinase delta…

Marketing permission for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test was given by the U.S. Food and Drug Administration. The test is approved for…

Patients who use insulin pumps or continuous glucose monitors (CGMs) are being asked by the Medicines and Healthcare Products Regulatory Agency (MHRA) to promptly report…

An adult COVID-19 vaccine (Comirnaty) that targets the KP.2 subvariant has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA). The immune system's…

Hympavzi (marstacimab-hncq) was approved by the U.S. Food and Drug Administration for routine prophylactic use in patients aged 12 and up who have hemophilia A…

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorized elafibranor (Iqirvo) for the treatment of adult patients suffering from primary biliary cholangitis (PBC), a…

Sugemalimab, also known as(Equijubi), has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat adult patients with "non-small cell lung cancer."…

The Medicines and Healthcare Products Regulatory Agency (MHRA) is advising medical practitioners to make sure patients are informed about the known adverse effects of agonists…

After an agency analysis of the available evidence found that oral phenylephrine is ineffective for this use, The U.S. Food and Drug Administration announced is…

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved new medicine containing active ingredient sparsentan to treat primary immunoglobulin A nephropathy (IgAN). IgA neuropathy,…

The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), a gene therapy based on an adeno-associated virus vector that is recommended for the treatment…

Following a review of its initial opinion, EMA suggests revising the recommendations to reduce the possibility of interactions between the weight loss medication Mysimba (naltrexone/bupropion)…

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine flortaucipir (Tauvid), a radiopharmaceutical product given to adults with memory problems so that…

The updated regulatory framework will expedite trial approvals and promote trial design innovation without affecting patient safety. New laws will be introduced in Parliament to…

The European Medicines Agency (EMA) has suggested expanding the use of Ofev (nintedanib) to treat progressive fibrosing interstitial lung disorders (ILDs) in children and adolescents…

The Holiday season is a busy time for all of us, our friends and our family. Consequently, we could overlook our health in the chaos…

European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union (EU) for Emcitate (tiratricol), an oral medication for individuals with peripheral…

The European Medicines Agency (EMA) has suggested that Welireg (belzutifan) be given a conditional marketing authorization in the EU for people with advanced renal cancer…

A recent study's findings indicate that Alofisel, a medication used to treat complex anal fistulas in adults with Crohn's disease, is ineffective. Based on the…

The U.S. Food and Drug Administration authorized the use of Crenessity (crinecerfont) in conjunction with glucocorticoids (steroids) to regulate the levels of androgen (a testosterone-like…

The U.S. Food and Drug Administration authorized Ryoncil (remestemcel-L-rknd), an allogeneic (donor) bone marrow-derived mesenchymal stromal cell (MSC) therapy in order to steroid-refractory acute graft-versus-host…

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the conditional marketing authorization of givinostat (Duvyzat), a medication used to treat Duchenne muscular dystrophy…

The U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that will offer suggestions for incorporating tissue biopsies into clinical…

The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved tarlatamab (Imdylltra) as a treatment for adult patients with small cell lung cancer (SCLC) that…

New approval by the Medicines and Healthcare products Regulatory Agency (MHRA) of the medicine sotatercept (Winrevair) to treat pulmonary arterial hypertension (PAH). Sotatercept is used, in…

Extra safety information is being added to all montelukast products, Montelukast is a prescription medicine used to prevent and treat chronic asthma in adults and…

If approved, the United States would be the world's first government to adopt such a bold, life-saving step to prevent and decrease smoking-related disease and…

The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved garadacimab (brand name Andembry) for the prevention of angioedema attacks in individuals aged 12 and…

The FDA has approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx alleviates…

The widespread use of azole fungicides (azoles), notably in some agricultural and horticultural operations, raises the possibility of Aspergillus fungus acquiring resistance to critical antifungal…

The EMA's human medicines committee (CHMP) has issued a good scientific opinion on Ivermectin/Albendazole for the treatment of illnesses caused by a variety of worm…

The Medicines and Healthcare Products Regulatory Agency (MHRA) has opened a consultation on regulatory guidance for personalized mRNA cancer immunotherapies (also known as cancer vaccines).…

The MHRA has authorized the chikungunya vaccine (live) (brand name IXCHIQ) to prevent adults from chikungunya disease, which is caused by the chikungunya virus (CHIKV).…

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the use of gozetotide (marketed under the name Illuccix) in a positioning emission tomography (PET)…

Nemolizumab, also known as Nemluvio, has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat moderate to severe prurigo nodularis in…

In order to provide vital safety alerts, the U.S. Food and Drug Administration is warning patients about a safety issue with diabetic devices that rely…

For the purpose of improving glycemic control in adults and pediatric patients with diabetes mellitus, the U.S. Food and Drug Administration authorized Merilog (insulin-aspart-szjj) as…

Adults with cerebrotendinous xanthomatosis (CTX) can now be treated with Ctexli (chenodiol), which is approved by the US Food and Drug Administration. Also, it's The…

A new clinical trial map is now available on the Clinical Trials Information System (CTIS) public website. The map is intended to offer patients and healthcare professionals…

The indication for post-operative pain management has been removed The indication for the management of post-operative pain has been removed from the licenses of all…

The Medicines and Healthcare Products Regulatory Agency (MHRA) has licensed mRNA respiratory syncytial virus (RSV) vaccine (brand name mRESVIA) to prevent individuals over the age…

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are warning the public about the risks of unregulated advanced therapy medical products…

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the triple combination medication deutivacaftor/tezacaftor/vanzacaftor (brand name Alyftrek) to treat cystic fibrosis (CF) in individuals…

In a single year, FDA educational efforts prevented about 450,000 young people from beginning to use e-cigarettes According to a research co-authored by scientists from…

Dystrophic Epidermolysis Bullosa (DEB) can be a very challenging condition to live with, & with the limited treatment options available on the market, which mainly…

Based on recent studies performed by the CHMP which included clinical trials, lab tests, real world evidence studies & bibliographical data. The European Medicines Agency…

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of trastuzumab deruxtecan (Enhertu) for treatment of people with HER-2 positive cancers that…

For most patients suffering from a chronic illness symptoms is of course their main struggling area, but what sometimes goes un noticed is the frequency…

As AI continues to reshape the future of healthcare, a significant milestone has been achieved. The European Medicines Agency’s (EMA) human medicines committee (CHMP) has…

A new chapter in in the UK medical research has begun which is more efficient, safer & smarter. With the biggest reform in over two…

Close monitoring of drugs side effects is a necessity, since leaving it un attended can lead to serious complications that on the long run maybe…

EMA’s continuous straining efforts to develop & improve biosimilar medicine has been ongoing for decades now. While still maintaining the strict European Union safety standards…

For years now Thyroid Eye Disease (TED) has been a struggle to anyone suffering from it, with limited treatment options available on hand & sometimes…

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Omaveloxolone (Skyclarys) as the first-ever treatment for Friedreich’s ataxia in patients aged 16 and…

Asthma Patients who rely solely on their blue inhalers may be putting their health at greater risk. That’s why The Medicines and Healthcare products Regulatory…

The UK’s Medicines & Healthcare Products Regulatory agency has approved Acoramidis (Beyonttra) for the treatment of adult patients with cardiomyopathy caused by transthyretin amyloidosis (ATTR-CM),…

As of 30 April 2025, a new formulation for Nivolumab has been approved by The Medicines and Healthcare products Regulatory Agency (MHRA) making the treatment…

The U.S. Food and Drug Administration (FDA) has taken the initiative to stop the use of concentrated ingestible fluoride present in prescription drugs of children.…

The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for obecabtagene autoleucel (Aucatzyl)—a CAR T-cell therapy—for the treatment of adult patients…

With Kaftrio being used for treatment of patients with Cystic Fibrosis, comes serious negative impact on patient’s psychological state. As of 25 February 2025, the…

The FDA has just recently approved a new blood test called The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, that helps with the early detection of…

As part of global efforts to protect the environment, the Medicines and Healthcare products Regulatory Agency (MHRA) is playing a role by supporting changes to…

EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC) recent review revealed negative mental health impact of finasteride and dutasteride on patients taking it for anti-hair loss…

With the AI being integrated in almost everything nowadays, FDA has decided to dive in and also integrate AI in their practice. AI has proven…

With the rising risk of antibiotics resistance, EMA’s human medicines committee (CHMP) has decided on readjusting the use of some antibiotics like azithromycin and limiting…

As of 16th of May 2025 Guselkumab (Tremfya) has been approved for the treatment of Crohn’s disease & Ulcerative colitis. However, it was initially used…

We now live in a time where innovation & technology are shaping our future from mobile phones to life saving inventions. The UK government has…

Non-arteritic anterior ischemic optic neuropathy, or NAION, is a very rare eye condition that causes vision loss; it affects 1 in 10,000 patients taking Semaglutide…

The EMA has published a draft guideline for public consultation that offers recommendations on how to include and/or continue pregnant and breastfeeding individuals in clinical…

With continuous efforts to find new cancer treatments, comes to life a new ultrasound technology developed by a US based company called HistoSonics the device…

In a significant advancement for lymphoma treatment, the FDA has approved Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for adults with relapsed or refractory…

Scopolamine transdermal patches were approved by the FDA in the 1970s for managing nausea and vomiting caused by motion sickness; later, they also got FDA…

Finding a treatment for hematological malignancies can be a challenging as it mainly depends on finding a suitable donor & if they are lucky enough…

On 24 June, the United Kingdom was the first country to join the HealthAI Global Regulatory Network, a new international initiative to ensure the safe and effective use of artificial intelligence (AI)…

With UK’s continuing efforts in providing better healthcare services & treatments for patients, comes the new initiative of providing at home cervical testing kits to…

The European Medicines Agency (EMA) has suggested granting provisional marketing authorization for Rezdiffra (resmetirom) the first treatment in the EU for noncirrhotic metabolic dysfunction-associated steatohepatitis…

Patients fighting extensive stage small cell lung cancer (SCLC) now have new hope with UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently approving serplulimab…

As of 1st of July 2025 regulations associated with the use of radioactive substances or ionizing radiation has changed to ease the process for applications…

Based on recent FDA findings the use of extended-release stimulants for ADHD management in children below 6 years old has been causing weight loss &…

The Saudi food & drug authority has been actively working towards advancing public health in kingdom through ongoing strategic initiatives aimed at strengthening the healthcare…

On July 2, 2025, the FDA gave accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a targeted therapy that helps the immune system attack cancer…

After deep review the EMA’s safety committee (PRAC) has decided on stopping the temporary restriction of people aged 65 years or older from getting the…

The FDA just recently placed investigational measures on Sarepta Therapeutics new medication “Elevidys” that has been indicated for treatment patients suffering from Duchenne muscular dystrophy…

Elinzanetant (Lynkuet) finally getting MHRA approval to provide relief for women suffering from menopausal symptoms. With Elinzanetant being the first non-hormonal therapy of its kind,…

The Medicines and Healthcare Products Regulatory Agency (MHRA) granted approval for EURneffy, the first intranasal adrenaline (epinephrine) treatment for emergency management of anaphylaxis, offering a…

People suffering from BCG-unresponsive non-muscle invasive bladder cancer now have a new hope with the recent approval of the Medicines and Healthcare Products Regulatory Agency…

The opioid epidemic, where almost one million Americans died due to improper use of opioids. Leading to the implementation of strict rules & changes in…

The Kingdom of Saudi Arabia has been working nonstop towards providing better healthcare solutions, keeping their promise of enhancing the healthcare sector as part of…

With FDA’s continuous efforts to provide high standard healthcare system comes the next step of providing a fast adverse reporting system, this milestone reflects a…

On the 21st of May Roche has identified a mistake in Evrysdi product labelling statement & SmPC as they found out it was missing out…

In coordination with the State Office for Health and Social Affairs Berlin (LAGeSo), Esteve Pharmaceuticals GmbH has reported regarding the presence of particles in some…

Immune thrombocytopenia an autoimmune disease known for having decreased platelets count which in turn results in frequent bruising & bleeding due to loss of clot…

On the 10th of September, the FDA approved KOSELUGO (selumetinib) granules & capsules for children 1 year or older who suffer from neurofibromatosis type 1…

The FDA has just released updated guidance on biosimilar development a big move for manufacturers navigating this space. The update proposes improved clarity, especially around…

The Food & Drug Administration has just launched the final guide for Good Clinical Practice Guidance E6(R3). The updated guideline introduces flexible, risk-based approaches to…

The new UK–US partnership will harness joint expertise in evolving technologies to deliver real-world benefits, from accelerating drug discovery with AI and quantum computing to…

Innovation is progressing each day & with the presence of AI things are starting to look different. Now AI is being utilized in various ways,…

A new study in Drug Safety presents the idea of “implied ADR-admissions” a method of using hospital and prescribing data to identify admissions likely caused…

Opioid misuse continues being a challenge in the United States, with it being prescribed to about 1 in 5 U.S adults who struggle with chronic…

Patients with von Willebrand disease (VWD) now have expanded treatment options, following the FDA’s approval of Vonvendi for prophylactic use in adults aged 18 and…

The Medicines & Healthcare Regulatory Agency (MHRA) has approved vorasidenib (Voranigo) for the treatment of adults and children aged 12 and older with specific types…

A new treatment path for patients with rare active immunoglobulin G4-related disease after the European Medicine’s Agency decided on extending the therapeutic indication of Uplizna (inebilizumab) to…

The FDA just recently approved first time treatment for patients struggling from Barth Syndrome, a rare life-threatening disease which affects the mitochondria, powerhouse of the…

The US FDA has been working in collaboration with GSK towards developing treatment to manage symptoms of patients struggling with autism, thereby on 22nd of…

On September 19, 2025, the U.S. Food and Drug Administration (FDA) approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph, Merck) for subcutaneous injection. It is the…

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that there is no evidence linking paracetamol use during pregnancy to autism in children. Dr…

April to June 2025 saw the FDA's Adverse Event Reporting System (FAERS) report a series of possible safety signals and new serious risk warnings for…

The Medicines and Healthcare products Regulatory Agency (MHRA), alongside the Advertising Standards Authority (ASA) and the General Pharmaceutical Council (GPhC), has issued an updated Enforcement…

The U.S. Food and Drug Administration (FDA) has authorized the marketing of Essilor Stellest eyeglass lenses, the first glasses designed to both correct nearsightedness (myopia)…

Acromegaly patients now have new hope after FDA recently approved Palsonify to treat adults who weren’t able to undergo surgery or had limited response to…

On September 25, 2025, the U.S. Food and Drug Administration granted approval to imlunestrant for adults with estrogen receptor (ER)–positive, HER2–negative, ESR1-mutated advanced or metastatic…

On October 3, 2025, the FDA launched a pilot prioritization program to speed up the review of abbreviated new drug applications (ANDAs) for companies that…

The SFDA launched a dedicated webpage on its website that provides access to draft guidelines under development for public consultation and private sector feedback, along…

The European Medicines Agency (EMA) has announced new safety measures for finasteride- and dutasteride-containing medicines to decrease the risk of suicidal ideation. These updates aim…

The U.S. Food and Drug Administration (FDA) has approved lurbinectedin (Zepzelca) in combination with atezolizumab (Tecentriq), or with atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza), as a…

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have announced the early rollout of their…

The U.S. Food and Drug Administration (FDA) is taking proactive steps to protect public health following alarming reports of diethylene glycol (DEG) and ethylene glycol…

The Saudi Food and Drug Authority (SFDA) has approved the registration of Qalsody (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS) linked…

On October 8, 2025, the U.S. Food and Drug Administration (FDA) approved Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adults with cutaneous squamous cell carcinoma…

The European Medicines Agency (EMA) in coordination with The Federal Institute for Drugs and Medical Devices (BfArM) has raised concerns regarding Caspofungin containing products, after…

Eisai GmbH, in agreement with the European Medicines Agency (EMA), has updated the MRI monitoring schedule for LEQEMBI (lecanemab) 100 mg/mL concentrate for infusion, a…

The FDA is now raising awareness regarding administration of tranexamic acid injections to be limited only to intravenous administration. There have been case reports where…

Artificial intelligence (AI) continues to redefine the future of healthcare, from detecting cancer faster to improving diagnostic accuracy across hospitals. The UK’s Medicines and Healthcare…

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched three government-funded initiatives that aim to make medicine development and regulation safer and more efficient…

The UK’s Innovative Licensing and Access Pathway (ILAP) aims to help patients get promising and much-needed new medicines more quickly. Announced by the Medicines and…

The Medicines and Healthcare products Regulatory Agency (MHRA) uncovered and shut down the UK's first illegal weight loss medicine factory during a raid on a…

The CEO of the Saudi Food and Drug Authority (SFDA), Dr. Hisham S. Aljadhey, has introduced the Saudi Pharmacopoeia at the Global Health Exhibition in…

The Saudi Food and Drug Authority (SFDA), led by CEO Dr. Hisham S. Aljadhey, has launched the Electronic Integration of Medications Risk Minimization Measures (RMMs)…

On October 24, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) approved Concizumab (Alhemo) to prevent or reduce the frequency of bleeding episodes in…

On October 23, 2025, the FDA approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a targeted B-cell maturation antigen (BCMA) antibody-drug conjugate, in combination with bortezomib and dexamethasone (BVd) for…

On October 24, 2025, the U.S. Food and Drug Administration approved Revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for adult and pediatric patients aged…

Damaged capsules have been identified in batches of Lenalidomide Mylan, with powder visible inside the blister pocket. For all strengths and pack sizes, healthcare professionals…

The Saudi Food and Drug Authority (SFDA) has launched the Regulatory AI System for Incoming Drugs (RASID), a smart service utilizing artificial intelligence to regulate…

The Saudi Food and Drug Authority (SFDA) has launched the National Network for Drugs and Medical Products Safety During Pregnancy and Breastfeeding. Unveiled at the…

Children and young adults, particularly university students, remain at risk from meningococcal meningitis and septicaemia, conditions that, while rare, can be devastating, life-changing, and sometimes…

The Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to overhaul the regulatory framework for rare disease therapies, aiming to speed up their…

A recent study carried out by UK’s Medicines and Healthcare products Regulatory Authority (MHRA) has revealed a huge variability in research methods associated with microbiome…

The U.S. Department of Health and Human Services (HHS) today took a historic step to bring evidence-based science back to women’s health. Following over 20…

The U.S. Food and Drug Administration (FDA) has approved significant safety updates for Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for Duchenne muscular dystrophy (DMD). The…

The U.S. Food and Drug Administration (FDA) has issued important guidance for generic drug manufacturers seeking waivers for differences in pH adjusters compared to reference…

The European Medicines Agency (EMA) is responsible for coordinating scientific evaluation, supervision, and safety monitoring of medicines in the European Union (EU). The EMA’s Health…

The Saudi Food and Drug Authority (SFDA) has signed a landmark agreement with Sweden's Uppsala Monitoring Centre (UMC), connecting Saudi Arabia's national pharmacovigilance database to…

An Expert Working Group (EWG) of the Commission on Human Medicines (CHM), advising the Medicines and Healthcare Products Regulatory Agency (MHRA), has completed an in‑depth…

The U.S. Food and Drug Administration (FDA) has announced the rollout of agentic artificial intelligence (AI) tools to all of its employees, marking a significant…

Active safety surveillance plays a vital role in ensuring the safety of vaccines and medicines after they are approved and introduced into clinical use. This…

The U.S. Food and Drug Administration (FDA) has qualified the first artificial intelligence tool for drug development, specifically AIM-NASH, designed to aid pathologists in evaluating…

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has reaffirmed the strong safety profile of hepatitis B vaccines routinely given to all babies. These…

The European Medicines Agency (EMA) has updated its post-authorization guidance in November 2025, clarifying variation classifications for marketing authorization holders. These revisions address administrative, quality,…

The European Medicines Agency (EMA) has welcomed the landmark political agreement reached by the European Commission, the European Parliament, and the Council of the European…

Good Clinical Practice (GCP) is a globally recognized set of ethical and scientific standards that govern how clinical trials involving human participants are designed, conducted,…

The European Medicines Agency (EMA) has published Revision 3 of the Guideline on Stability Testing for Applications for Variations to a Marketing Authorization, introducing updated…

The U.S. Food and Drug Administration (FDA) has announced a significant update to its approach to real-world evidence (RWE), removing a major limitation that has…

Intranasal esketamine has been a focal point of psychiatric innovation for treatment of resistant depression, yet its transition from controlled clinical trials to broad real-world…

Healthcare systems today generate enormous volumes of data from electronic health records, medical imaging, wearable devices, genomic databases, and real-time patient monitoring. While this data…

In the current pediatric healthcare landscape, ensuring medication safety for children remains a critical challenge for global medical science. While adverse drug reactions (ADRs) are…

The UK government has officially launched a pioneering £2 million vaccination pilot program designed to bring life-saving protection directly to families. This initiative empowers NHS…

The FDA maintains a rigorous post-market surveillance system to protect public health through advanced Pharmacovigilance. Central to this is the FAERS (FDA Adverse Event Reporting…

The Saudi Food and Drug Authority (SFDA) recently held a high-level meeting with the National Committee of Pharmacies of the Federation of Saudi Chambers to…

FDA has requested that drug manufacturers remove suicidal ideation and behavior (SI/B) warnings from the labeling of three GLP-1 receptor agonist (GLP-1 RA) medications used…

A comprehensive pharmacovigilance study recently published in the Saudi Pharmaceutical Journal has provided critical real-world evidence regarding the association between three major antibiotic classes and…

A new study published in Drug Safety reveals significant limitations in commonly used anticholinergic burden (ACB) scales, showing they fail to fully capture real-world adverse drug reactions…

Artificial intelligence (AI) is rapidly reshaping the way medicines are discovered, developed, evaluated, and monitored. Recognizing both its transformative potential and its inherent risks, international…

A newly published systematic review and meta-analysis in The Lancet Obstetrics, Gynecology, & Women’s Health has provided reassuring evidence regarding the safety of paracetamol use…

Overview The Saudi Food and Drug Authority (SFDA) announced a notable 18% increase in licensed factories and warehouses during 2025 compared to 2024, reflecting the…