Federal Register notice: FDA updates its current listing of medical devices that have received an Emergency Use Authorization during the Covid-19 pand...
Provention Bio refiles its BLA for teplizumab for the delay of clinical Type 1 diabetes in at-risk individuals.
FDA approves Bristol-Myers Squibbs Opdualag to treat some adults and pediatric patients with melanoma.
The Association for Accessible Medicines gives its views on Department of Justice and Federal Trade Commission efforts to modernize merger enforcement...
FDA says it has reached an agreement with representatives of the medical device industry on the MDUFA 5 reauthorization provisions.
FDA clears a Quantum Surgical 510(K) for its Epione, described as a robotic-assisted device designed to plan, target, deliver and confirm tumor ablati...
Federal Register notice: FDA establishes a docket to solicit comments that will assist the agency in determining how best to prioritize the addition o...
Federal Register notice: FDA corrects a 3/10 notice on a draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Cer...