FDA warns Chinas Sichuan Deebio Pharmaceutical Co. about significant deviations in manufacturing active pharmaceutical ingredients.
A report of a patients liver failure leads to an FDA clinical hold against two RAPT Therapeutics Phase 2 trials involving zelnecirnon (RPT193).
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...
