A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit ...

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

Recent Complete Response Letters (CRL) issued to Replimune and Capricor have made the FDA’s new and intensified scrutiny of clinical trial design clear. As the agency demands greater rigor and clarity ...

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 ...

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, ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

The FDA has decided not to approve vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.

Why: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf ...

SAN FRANCISCO, July 23, 2025 (GLOBE NEWSWIRE) -- Investors in Replimune Group, a biotechnology company focused on cancer treatments, witnessed a dramatic collapse in their holdings on July 22. Shares ...

Iova stock jumps 31% amid FDA setback for rival, short squeeze buzz, and rising momentum for Amtagvi melanoma therapy.