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.
FDA makes recommendations to prevent damage to wearable medical devices from X-ray imaging, including CT scans.
FDA warns Koreas Outin Futures Corp. about CGMP and misbranding violations at its drug manufacturing facility.
