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Senator Tom Cotton (R-AR) urges FDA and government cybersecurity officials to review Chinese-made medical devices cleared before u...[ Price : $8.95]
A Yale Journal on Regulation article from the Yale Law School Solomon Center for Health Law & Policy examines how the Supreme Cour...[ Price : $8.95]
FDA issues an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by ...[ Price : $8.95]
A regulatory expers says FDAs recent draft guidance on Form-483 responses is signaling tougher expectations for how drug manufactu...[ Price : $8.95]
Biogen and Denali Therapeutics limit the development of their experimental Parkinsons disease drug BIIB122 after the therapy faile...[ Price : $8.95]
FDA approves Daiichi Sankyos Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic triple-negative bre...[ Price : $8.95]
FDA has approved Gilead Sciences Hepcludex (bulevirtide-gmod) for treating chronic hepatitis delta virus (HDV) infection, marking ...[ Price : $8.95]
Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in drug development.