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#EMA

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Oct 15Thu
  1. ema.europa.eu90

    EMA recommends authorisation of Rasonque for metastatic pancreatic cancer

    EMA's CHMP has recommended EU marketing authorisation for Revolution Medicines' Rasonque (daraxonrasib), an oral RAS inhibitor for adults with metastatic pancreatic adenocarcinoma previously treated at least once. In a 500-patient phase 3 study, median overall survival was 12.4 months versus 6.7 with chemotherapy, and median progression-free survival 7.2 versus 3.6 months. The European Commission will now fast-track its decision, with pricing left to Member States.

    Why it matters: CHMP backing via a phased review under 150 days sets precedent for faster EU assessments of priority cancer medicines.

Oct 9Fri
  1. ema.europa.eu55

    Clinical trial applications advice pilot becomes permanent

    The EMA's Accelerating Clinical Trials in the EU (ACT EU) advice pilot, which gives sponsors consolidated pre-submission feedback from Member States on clinical trial applications via CTIS, will become permanent from January 2027. The procedure is coordinated by the Heads of Medicines Agencies through its Clinical Trials Coordination Group. A final report covering roughly 30 pilot applications is due before the end of 2026, with updated guidance and templates published in January 2027.

Sep 18Fri
  1. ema.europa.eu40

    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026

    The EMA's CHMP recommended 12 new medicines for approval at its September 2026 meeting, including Frehemgo (denecimig) for bleeding prophylaxis in haemophilia A, Gevalka (ensartinib) for ALK-positive advanced non-small cell lung cancer, and Povofortay (povorcitinib), the first oral daily treatment for adults with hidradenitis suppurativa refractory or intolerant to anti-TNF therapy. Two initial marketing authorisation applications were withdrawn, Isembyld for 5q spinal muscular atrophy and Zinmyleo for chemotherapy-induced myelosuppression. Re-examinations of negative opinions for Kemsu, Meplyffa and Qezzaqar will follow once grounds are received.

Sep 4Fri
  1. ema.europa.eu45

    Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026

    EMA's Pharmacovigilance Risk Assessment Committee has begun a review of all injectable iron-containing medicines over risks of hypophosphataemia and related bone problems such as osteomalacia. The review was triggered by reports questioning the effectiveness of current risk-minimisation measures for ferric carboxymaltose products, including serious cases after only one or two doses in people without recognised risk factors. PRAC will assess the benefit-risk balance and decide whether changes to marketing authorisations are needed.

    Why it matters: A EU-wide safety review of all injectable iron medicines could change prescribing and product information for iron deficiency anaemia.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org