PDC Pharma Strategy CEO Penelope Przekop says there are several reasons why the drug industry is not rapidly moving toward quality management programs...
Federal Register notice: FDA extends the comment period on a 12/22 notice for its Master Protocols for Drug and Biological Product Development draft g...
FDA grants accelerated approval to Iovance Biotherapeutics for Amtagvi, a cellular therapy indicated for treating certain adult patients melanoma.
FDA accepts for priority review a Sarepta Therapeutics supplemental BLA for Elevidys (delandistrogene moxeparvovec-rokl) to convert the earlier accele...
FDA approves a Novartis supplemental BLA for Xolair (omalizumab) for reducing allergic reactions related to accidental exposure to one or more foods.
Federal Register notice: FDA amends a 12/12/2023 notice requesting nominations for voting members to serve on CDERs Genetic Metabolic Diseases Advisor...
Gilead Sciences pauses enrollment globally in its magrolimab solid tumor studies and FDA subsequently requests (XXX TENSE XXX) a partial clinical hold...
CDRH Office of Product Evaluation and Quality (OPEQ) director William Maisel announces he will retire this spring.
