Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...

Rosen Law Firm, a global investor rights law firm, announces it has filed a class action lawsuit on behalf of purchasers of the securities of Replimune Group, Inc. (NASDAQ: REPL) between November 22, ...

During a live event, Mark Yarchoan, MD, and participants reviewed adverse event management for 3 different combination ...

Dispatch Bio launched with $216 million – backed primarily by Parker Institute for Cancer Immunotherapy, founded by entrepreneur Sean Parker, and ARCH Venture Partners. SAB BIO announced an ...

A 55-year-old man’s swollen toes and fingers turned out to have a much stranger explanation than expected. In a recent case ...

The gene therapy developer is cutting 30% of its workforce. Elsewhere, Abivax secured a major cash infusion, while Novartis and Eli Lilly struck small research deals.