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.
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances on the design of bioequivalence studies...
FDA grants Diamyd Medical a fast-track designation for Diamyd (rhGAD65/alum) and its use in improving glycemic control in some diabetes patients.
FDA clears a Merit Medical Systems 510(k) for the SCOUT MD Surgical Guidance System for use in implanting surgical reflectors in abnormal breast tissu...
