FDA accepts an sNDA for AstraZenecas Tagrisso cancer drug and will give it priority review.
FDA clears an Ezra 510(k) for its artificial intelligence and its use in assisting radiologists in their analysis of prostate MRI scans.
FDAs Medical Device Development Tools program lists an agency-qualified tool that medical device sponsors can use in developing and evaluating medical...
FDA releases its latest batch of Warning Letters that include Medoz Pharmacy of Polk and RLC Labs.
Federal Register notice: FDA announces the Web site location where it will post two lists outlining guidance documents that CDRH intends to publish in...
Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve on cert...
FDA clears an Ossio 510(k) for its Ossiofiber Compression Screw Portfolio for alignment maintenance and fixation of bone fractures.
FDA grants full approval for AbbVie and Roches Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine for treat...