FDA places a clinical hold on the Novavax IND for a Covid-19/influenza combination vaccine and influenza standalone vaccine following a report of one ...
FDA publishes a guidance reflecting GDUFA 3 provisions on the procedures for ANDA applicants to follow in requesting reconsideration of scientific iss...
FDA clears a Bracco Diagnostics and Subtle Medical 510(k) for their artificial intelligence-powered software AiMify for brain MRIs.
Novocure wins PMA approval for Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for treating adult patients with metastatic non-s...
The DC federal court rules in favor of FDA and MSN Pharmaceuticals as defendants in a suit filed by Novartis over the agencys approval of MSNs generic...
Jazz Pharmaceuticals plans to file a supplemental NDA next year following positive top-line results from its Phase 3 clinical trial evaluating Zepzelc...
CDER director Patrizia Cavazzoni says the Center worked with CBER to launch in 2023 the START program, providing selected participants enhanced commun...
FDA posts a consumer-focused explanation of how CDER determines and manages drug shortages.
