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Agios files a supplemental NDA for an expanded indication for its Pyrukynd (mitapivat) for treating adult patients with alpha- or ...[ Price : $8.95]
FDA clears an AngioDynamics 510(k) for the NanoKnife System for prostate tissue ablation.[ Price : $8.95]
AbbVie announces positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as an early Parkinson's dise...[ Price : $8.95]
Chimerix plans to submit an NDA before the end of the year seeking accelerated approval for dordaviprone for treating recurrent H3...[ Price : $8.95]
FDA releases an 11-item Form FDA-483 from a 10/2023 Fresenius Kabi Oncology inspection at the companys Pradesh, India manufacturin...[ Price : $8.95]
FDA posts a final guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Biore...[ Price : $8.95]
Federal Register notice: FDA announces a 2/5 joint meeting of its Drug Safety and Risk Management Advisory Committee and Anestheti...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Expedited Program for Serious Conditions Accelerated Appro...