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 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.
Federal Register notice: FDA determines that Merck Sharp & Dohmes Noxafil (posaconazole) 100g delayed-release tablets were not withdrawn from sale due...
Federal Register notice: FDA issues IntraBio a priority review voucher after determining its recent approval of Aqneursa (levacetylleucine) qualified ...
FDA releases the form FDA-483 with 14 observations issued following an inspection at the Edmond, OK-based Qualgen outsourcing facility.
