Agios files a supplemental NDA for an expanded indication for its Pyrukynd (mitapivat) for treating adult patients with alpha- or beta-thalassemia.
FDA clears an AngioDynamics 510(k) for the NanoKnife System for prostate tissue ablation.
AbbVie announces positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as an early Parkinson's disease therapy.
Chimerix plans to submit an NDA before the end of the year seeking accelerated approval for dordaviprone for treating recurrent H3 K27M-mutant diffuse...
FDA releases an 11-item Form FDA-483 from a 10/2023 Fresenius Kabi Oncology inspection at the companys Pradesh, India manufacturing facility.
FDA posts a final guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (B...
Federal Register notice: FDA announces a 2/5 joint meeting of its Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug...
Federal Register notice: FDA makes available a draft guidance entitled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Bio...
