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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 ...
The latest details of Indonesian Vice President Gibran Rakabuming Raka's assets show a Rp1.9 billion increase.
The Corruption Eradication Commission (KPK) has released the Wealth Report of State Officials (LHKPN) for President Prabowo ...
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.
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.
Replimune Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...
Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Replimune Group, Inc. ("Replimune or the "Company") (NASDAQ: REPL).