The US Food and Drug Administration on Thursday issued recommendations for the composition of influenza shots for the ...

Amneal announced FDA acceptance of its Biologics License Application (BLA) for two proposed denosumab biosimilars ...

The FDA has accepted the resubmission of a BLA for odronextamab for the treatment of patients with relapsed/refractory ...

As the company prepares for its regulatory meetings ... Licensing Application (BLA) submission, expected in the second quarter of 2025, and anticipates FDA approval within six months of filing.

Regenxbio Inc (RGNX) showcases robust financial positioning and strategic progress in gene therapy, despite challenges in ...

Capricor Therapeutics (CAPR) announced the U.S. Food and Drug Administration has accepted for review its Biologics License Application seeking ...

Outlook Therapeutics has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) ...

Three Democratic senators want answers from Health and Human Services Secretary Robert F. Kennedy Jr. about his private meetings with drugmakers alongside President Trump at his Mar-a-Lago club in ...

FDA grants Priority Review to Capricor's deramiocel for Duchenne cardiomyopathy, setting an August 2025 decision date with no ...

A Prescription Drug User Fee Act target date of December 16, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for review the Biologics License ...