annb0t
Top 20
Pfizer PFE announced that its regulatory submissions in the United States and European Union (âEUâ) seeking approval for hemophilia B gene therapy treatment fidanacogene elaparvovec have been accepted for review.
While a final decision of the FDA is expected in second-half 2024, a decision from the European Medicines Agency (EMA) is anticipated in mid-2024.
The regulatory filings for fidanacogene elaparvovec in both markets are based on data from the phase III BENGENE-2 study. The st...
>>> Read more: FDA Accepts Pfizer's (PFE) Hemophilia B Gene Therapy Filing
While a final decision of the FDA is expected in second-half 2024, a decision from the European Medicines Agency (EMA) is anticipated in mid-2024.
The regulatory filings for fidanacogene elaparvovec in both markets are based on data from the phase III BENGENE-2 study. The st...
>>> Read more: FDA Accepts Pfizer's (PFE) Hemophilia B Gene Therapy Filing
