The FDA has granted an in-person Type C meeting during the first quarter of 2026 New independent analyses across large observational ALS cohorts ...
Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering first-in-class therapeutics based on small-molecule inhibition of CLK/DYRK kinases, announced today that ...
ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal ...
A new drug application (NDA) has been submitted to the FDA seeking approval of rusfertide, an investigational hepcidin ...
The U.S. Food and Drug Administration (FDA) on Thursday extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for Cytokinetics Inc's (NASDAQ:CYTK) ...
Following submission on June 16, the NDA was accepted for review as a “complete class 2 response” by the FDA on July 16, 2025, with a target PDUFA action date of December 16. Also Read: FDA Rejects ...
Sevabertinib shows promise for advanced NSCLC with HER2 mutations, achieving a 72.1% objective response rate in the SOHO-01 trial. Patients with HER2 YVMA insertions exhibited a 90% objective response ...
Corcept Therapeutics CORT announced that the FDA has accepted the new drug application (NDA) seeking approval for its lead pipeline candidate, relacorilant, for treating patients with ...
Disc Medicine, Inc., a biopharmaceutical company focused on treatments for hematologic diseases, announced positive feedback from its pre-New Drug Application (NDA) meeting with the FDA regarding its ...
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