Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...
ST. PETERSBURG, Fla. (WFLA) — The President of the Tampa Bay Rays has sent a response letter to the Pinellas County Board of County Commissioners following the letter to the baseball team last week.
WOBURN, Mass., July 22, 2025 (GLOBE NEWSWIRE) -- Replimune Group (REPL), Inc. , a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced ...
When the FDA turns down a drug application, it has historically been up to the drug company to reveal it. These FDA complete response letters, or CRLs, have not been considered public documents.
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