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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…

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…

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…

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…

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

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…

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…

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…

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…

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…

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

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…

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…