Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority ...

The FDA has set a Prescription Drug User Fee Act action date for 24 May 2026.

If approved, marstacimab would be the first non-factor prophylactic treatment indicated for pediatric patients aged 6 to 11 years with hemophilia B.

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License Application, or sBLA, for Dupixent to treat adults and pediatric ...

Pfizer today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the ...

Japan’s Eisai and US biotech Biogen have announced that the US Food and Drug Administration (FDA) has accepted for review the ...

F8 formulation intended to replace EGRIFTA SV ® with simplified dosing for the treatment of excess abdominal fat in adults with HIV and lipodystrophy MONTREAL, Nov. 26, 2024 (GLOBE NEWSWIRE) -- ...

The U.S. FDA has accepted and granted Priority Review for Pfizer’s supplemental Biologics License Application (sBLA) for HYMPAVZI.

Ascendis Pharma (ASND) announced that the FDA has accepted for review its supplemental biologics license application, or sBLA, in adult growth hormone deficiency, or GHD, for TransCon hGH. The FDA set ...

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is ...

BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep ...

On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application (“sBLA”) for Dupixent (dupilumab) in the treatment of ...