Seven new advanced therapy medicinal products (ATMPs) could be approved for pan-EU approval this year, based on data from the Pink Sheet’s EU regulatory filings tracker, including Roche/Sarepta Therapeutics’ Duchenne gene therapy delandistrogene moxeparvovec, known as Elevidys in the US and several other nations where it is already approved.
Why 2025 Could See A Surge In EMA Approval Opinions For ATMPs
Seven ATMPs Could Be Backed For Pan-EU Approval In 2025
Marketing authorization applications for five new advanced therapy medicinal products were filed with the European Medicines Agency in 2024, the highest number in any year since 2020. The Pink Sheet looks at these and two other ATMPs that might get the thumbs up from the European Medicines Agency in 2025.
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