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® ...

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 ...

The extension was needed to review newly submitted long-term clinical data for all patients in the pivotal study following an FDA information request.

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 ...

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 ...

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