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FDA dismisses concerns raised in a JAMA Internal Medicine report that many medical device adverse event reports involving a patien...[ Price : $8.95]
FDA clears a TransMedics Group 510(k) for its OCS Lung Solution for use in transplants using cold storage techniques.[ Price : $8.95]
FDA approves GlaxoSmithKlines Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5, as a treatment for patients ...[ Price : $8.95]
FDA says Emergent BioSolutions can resume producing J&J Covid-19 vaccine at its Bayview manufacturing facility.[ Price : $8.95]
FDA approves Mylans Semglee, the first biosimilar and interchangeable insulin product approved in the U.S.[ Price : $8.95]
Federal Register notice: FDA determines that Eli Lillys Ceclor CD (cefaclor extended-release tablets) 375 mg and 500 mg were not w...[ Price : $8.95]
Federal Register notice: CDER and CBER announce the effective date of 9/15 for using Electronic Common Technical Document validati...[ Price : $8.95]
Federal Register notice: FDA determines that Bausch Health Americas Efudex (fluorouracil) topical solution, 5%, was not withdrawn ...