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) ...
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 ...
Lexicon Pharmaceuticals announced that it received a complete response letter (CRL) from the FDA regarding its New Drug Application for Zynquista™ (sotagliflozin), which was proposed as an adjunct to ...
Capricor plans to resubmit its BLA to the FDA, incorporating data from the ongoing Phase 3 HOPE-3 trial, indicating proactive steps toward potential approval for Deramiocel. The FDA's invitation for ...
When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view into the high-stakes discussions that decide whether a medicine will ever make ...
A letter from Emil Bove, acting deputy attorney general, accepting the resignation of Danielle R. Sassoon, Manhattan’s acting U.S. attorney, over her refusal to drop the case against Mayor Eric Adams.
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