Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two EYLEA HD® ...

Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company focused on recombinant protein-based vaccines using nanoparticle and ...

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced the initiation of a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking ...

Pharmaceuticals announced that the Food and Drug Administration has extended the target action dates to Q4 of 2025 for two Eylea ...

Ultragenyx Pharmaceutical ( ($RARE) ) just unveiled an announcement. On August 18, 2025, Ultragenyx Pharmaceutical announced the start of a ...

In this Healio Video Perspective from the Retina World Congress, Huma Qamar, MD, MPH, of Ocugen, overviews programs for ...

Checkpoint Therapeutics Announces Biologics License Application Resubmission for Cosibelimab PRESS RELEASE GlobeNewswire Jul. 2, 2024, 07:00 AM ...

--Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, today confirmed that it will file its Biologics License Application for approval of Ryoncil ® in the ...

In May 2023, FDA conducted the Pre-License Inspection (PLI) of the manufacturing process for remestemcel-L, and this did not result in the issuance of any Form 483.

Merck (MRK) announced the FDA has accepted the Biologics License Application, or BLA, for clesrovimab, the company’s investigational prophylactic long-acting monoclonal antibody designed to ...