The FDA declined approval of Darzalex Faspro for newly diagnosed, transplant-ineligible multiple myeloma in its current form.

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

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® ...

Boehringer Ingelheim & AnGes sign manufacturing agreement for HGF gene therapy product: Ingelheim, Germany Thursday, August 21, 2025, 09:00 Hrs [IST] Boehringer Ingelheim, a bioph ...

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 ...

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

RARATIN, N.J., June 17, 2024/ PRNewswire/-- Johnson& Johnson announced today the submission of a Biologics License Application to the U.S. Food and Drug Administration for a fixed combination of ...

Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept) Published Feb 18, 2025 6:00am EST ...

A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully human monoclonal antibody to treat individuals with spinal muscular ...