Iberdomide has the potential to be the first approved CELMoD agent The U.S. FDA has granted Breakthrough Therapy Designation and Priority Review for this indication and assigned a target action date ...
FDA Issued Complete Response Letter Citing Outstanding Items Related to Chemistry, Manufacturing, and Controls and Non-Clinical Information FDA ...
Gedatolisib targets HR+/HER2-, PIK3CA wild-type advanced breast cancer, with a PDUFA goal date of July 17, 2026. The drug's multi-target approach inhibits all four class 1 PI3K isoforms, mTORC1, and ...
NEW HAVEN, Conn., Jan. 20, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines ...
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