On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...
Aquestive's issues are more likely related to manufacturing or packaging rather than efficacy or safety. See why I'm ...
Disc is seeking accelerated approval and priority review of its NDA submission FDA decision to accept and file the NDA for review occurs within 60 days of submission WATERTOWN, Mass., Sept. 30, 2025 ...
Vanda Pharmaceuticals announced it received a decision letter from the FDA’s Center for Drug Evaluation and Research (CDER) stating that the supplemental New Drug Application (NDA) for Hetlioz ...
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 ...
The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review within 30 days of submission, and completion of submission review within 6 ...
A new drug application (NDA) has been submitted to the FDA seeking approval of rusfertide, an investigational hepcidin ...
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 ...
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