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EMA Backs 12 New Medicines, Alongside Key Label Expansions

Summary by EU Reporter
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended 12 new medicines for approval at its September 2026 meeting, while backing extensions of indication for 11 existing medicines. Among the new medicines, the CHMP recommended Novo Nordisk’s Frehemgo (denecimig) for preventing bleeding episodes in people with haemophilia A. “The recommendation […]
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8 Articles

DeiaDeia
+3 Reposted by 3 other sources

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that Gevalka (ensartinib) be given marketing authorisation to treat an advanced type of non-small cell lung cancer with positive expression of anaplastic lymphoma kinase.

·Bilbao, Spain
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What did the officials of the European Medicines Agency announce today?

New treatments for, among others, hemophilia, lung cancer and myasthenia gravis are among the drugs recommended for approval after the September meeting of the EMA's expert committee.

The Committee for Medicinal Products for Human Use recommended the approval of 12 new medicines and the extension of indication for others 11. Among the novelties: an anti-rabic vaccine, a therapy for myasthenia gravis and two biosimilars. Retreat the questions for two medicines intended for rare diseases. The post Da Ema free to 12 new drugs. Among these the first oral treatment for reverse acne appeared first on Quotidiano Sanità.

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quotidianosanita.it broke the news on Friday, September 18, 2026.
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