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 ...

Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and Medincell announced that the supplemental New Drug ...

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

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

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, ...

Longitudinal ALS patient data from APST Research will enable a more robust analysis of the effect of CNM-Au8 on NfL biomarkers; APST Research data includes thousands of people liv ...

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

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

The Company submitted an sNDA for ZORYVE foam for scalp and body psoriasis to the FDA based on the positive results from the pivotal ARRECTOR Phase 3 trial and a Phase 2b trial, which was accepted by ...