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

Outlook Therapeutics (OTLK) announced it has re-submitted its Biologics License Application, BLA, to the U.S. Food and Drug Administration, ...

The FDA granted priority review to TLX250-CDx for clear cell renal cell carcinoma imaging, with a PDUFA date of August 27, ...

We remain committed to bringing an ophthalmic bevacizumab to market in the United States and providing retina patients suffering from wet AMD with a much needed treatment option that has the potential ...

Regeneron Pharmaceuticals (NASDAQ:REGN) said on Wednesday that the U.S. FDA has accepted its resubmitted Biologics License ...

The FDA granted RMAT designation to nogapendekin alfa and CAR-NK for reversing lymphopenia in patients with cancer, with ...

After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

Capricor Therapeutics filed a BLA for deramiocel, showing promising results in slowing cardiac dysfunction in DMD ...

The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics ...