Attorney Deborah Livornese says FDA wants user feedback on the NDA integrated review format it has been publishing for several years.
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...
FDA accepts for priority review a GSK NDA for gepotidacin, a first-in-class oral antibiotic for treating female adults and adolescents with uncomplica...
FDA commissioner Robert Califf and two colleagues discuss the agencys role in regulating artificial intelligence in biotechnology and healthcare.
