U.S. Food and Drug Administration

February 24, 2021February 24, 2021

Tebentafusp Named FDA Breakthrough Therapy for Advanced Eye Cancer

News

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Immunocore‘s tebentafusp (IMCgp100) for HLA-A2 positive, inoperable, or advanced uveal melanoma — a common and difficult-to-treat form of ... Read more

December 7, 2020December 7, 2020

FDA Approves Less Frequent Treatment Regimen for Imfinzi in NSCLC, Bladder Cancer

News

The U.S. Food and Drug Administration (FDA) has approved a new dosing regimen for Imfinzi (durvalumab) for the treatment of certain non-small cell lung cancer (NSCLC) and bladder cancer patients. Granted under priority review, ... Read more

March 14, 2017

CEL-SCI Working with FDA to Lift Hold on Phase 3 Trial of Multikine for Head and Neck Cancer

News

CEL-SCI Corp. has received the official minutes from its Type A (face-to-face) meeting with the U.S. Food and Drug Administration (FDA) concerning the partial clinical hold placed on a Phase 3 ... Read more