The FDA Has Accepted Pfizer's Biologics License Application For Fidanacogene Elaparvovec For The Treatment Of Adults With Hemophilia B; The FDA Has Set A PDUFA Goal Date In Q2 Of 2024
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The FDA has accepted Pfizer's Biologics License Application for Fidanacogene Elaparvovec, a treatment for adults with Hemophilia B. The FDA set a PDUFA goal date in Q2 of 2024. The European marketing authorization application has also been accepted and is under review by the EMA.
June 27, 2023 | 10:47 am
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Pfizer's Fidanacogene Elaparvovec treatment for Hemophilia B has been accepted by the FDA and EMA, potentially expanding the company's product offerings and revenue streams.
The FDA's acceptance of Pfizer's Biologics License Application for Fidanacogene Elaparvovec indicates a positive step towards the treatment's approval and commercialization. This could lead to an expansion of Pfizer's product offerings and increased revenue from the new treatment. The European marketing authorization application's acceptance by the EMA further supports the potential for global market expansion.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100