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Dyne Therapeutics submits a BLA that seeks accelerated approval for its experimental Duchenne muscular dystrophy therapy z-rostudi...[ Price : $8.95]
FDA Matters founder Steven Grossman explains why he thinks it will take the Trump administration at least until the end of the yea...[ Price : $8.95]
Senator Tom Cotton (R-AR) urges FDA and government cybersecurity officials to review Chinese-made medical devices cleared before u...[ 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]
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A regulatory expers says FDAs recent draft guidance on Form-483 responses is signaling tougher expectations for how drug manufactu...