A New Drug Application has been accepted seeking accelerated approval for dordaviprone for patients with recurrent H3 ...

Teva Pharmaceuticals (TEVA) and Medincell (MEDCL) announced that the supplemental New Drug Application sNDA for UZEDY extended-release ...

Porosome Therapeutics, Inc. announced the Orphan Drug Designation of its cystic fibrosis therapy by the Food and Drug Administration (FDA).

The FDA has accepted a supplemental New Drug Application submitted by Teva (NYSE:TEVA) and Medincell (OTC:MDCLF) for Uzedy ...

UZEDY is currently approved for use every one or two months as a subcutaneous long-acting injectable (LAI) for the treatment ...

The FDA accepted for priority review a supplemental Biologics License Application for Keytruda for resectable locally ...

The FDA granted priority review to pembrolizumab for neoadjuvant and adjuvant use in head and neck squamous cell carcinoma, ...

Gilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission ...

Company has Completed all Supplemental Testing and has Submitted its Formal Response to the FDA’s Additional Information Request (AIR) ...

(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in ...

The inspection took place at the company’s sterile API manufacturing unit in Visakhapatnam, located in Jawaharlal Nehru Pharma City (JNPC).