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Federal Register notice: FDA extends the comment period on a 12/22 notice for its Master Protocols for Drug and Biological Product...[ Price : $8.95]
FDA grants accelerated approval to Iovance Biotherapeutics for Amtagvi, a cellular therapy indicated for treating certain adult pa...[ Price : $8.95]
FDA accepts for priority review a Sarepta Therapeutics supplemental BLA for Elevidys (delandistrogene moxeparvovec-rokl) to conver...[ Price : $8.95]
FDA approves a Novartis supplemental BLA for Xolair (omalizumab) for reducing allergic reactions related to accidental exposure to...[ Price : $8.95]
Federal Register notice: FDA amends a 12/12/2023 notice requesting nominations for voting members to serve on CDERs Genetic Metabo...[ Price : $8.95]
Gilead Sciences pauses enrollment globally in its magrolimab solid tumor studies and FDA subsequently requests (XXX TENSE XXX) a p...[ Price : $8.95]
CDRH Office of Product Evaluation and Quality (OPEQ) director William Maisel announces he will retire this spring.[ Price : $8.95]
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances on the design of bi...