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.
Federal Register notice: FDA makes available a final guidance entitled Temporary Policies for Compounding Certain Parenteral Drug Products.
