The EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded its January 2026 session with a range of key regulatory recommendations that could shape the European pharmaceutical landscape. During the meeting, the CHMP: New Medicines Recommended for Approval The CHMP issued positive opinions on six new medicines, including: Fylrevy (estetrol) – a hormone replacement […]
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 development and availability for the approximately 3.5 million people in the UK are affected by rare diseases, about one in every 17 people. Currently, fewer than 5% of rare diseases […]
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 1 year and older with relapsed or refractory acute myeloid leukemia (AML) having a susceptible nucleophosmin 1 (NPM1) mutation and no satisfactory alternative treatments. The approval was based on the […]
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 adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. The efficacy of belantamab mafodotin-blmf […]
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 people aged 12 years and older with haemophilia A or B with inhibitors. Haemophilia is a rare hereditary condition where blood clotting is impaired due to a deficiency of clotting […]
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 (CSCC) at high risk of recurrence following surgery and radiation therapy. This approval marks an important advancement for patients with high-risk CSCC, offering a new option to help reduce disease […]
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 with mutations in the superoxide dismutase 1 (SOD1) gene. ALS is a rare and progressive motor neuron disease that disturbs the nerve cells controlling voluntary movement, leading to increasing muscle […]
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 maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after initial therapy. Efficacy was assessed in the IMforte trial (NCT05091567), a randomized, multicenter, […]
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 breast cancer who have progressed after at least one line of endocrine therapy. To identify patients eligible for treatment, the FDA also approved the Guardant360 CDx assay as a companion […]
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 surgery, giving them hope with better outcomes. Acromegaly is a rare endocrine disorder in which the pituitary gland produces excessive growth hormone (GH), usually because of a non-cancerous tumor. This […]
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