Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

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

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 ...

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 ...

Replimune Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...

Replimune (REPL) stock plummeted on Tuesday after the biotechnology company received a Complete Response Letter (CRL) from ...

Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Replimune Group, Inc. ("Replimune or the "Company") (NASDAQ: REPL).

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...