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FDA warns Chinas Sichuan Deebio Pharmaceutical Co. about significant deviations in manufacturing active pharmaceutical ingredients...[ Price : $8.95]
A report of a patients liver failure leads to an FDA clinical hold against two RAPT Therapeutics Phase 2 trials involving zelnecir...[ Price : $8.95]
PDC Pharma Strategy CEO Penelope Przekop says there are several reasons why the drug industry is not rapidly moving toward quality...[ Price : $8.95]
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...