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 publishes for public comment 29 new and 33 revised product-specific guidances.
FDA commissioner Robert Califf says the recent worldwide reporting of a call to end Covid vaccines by the Florida surgeon general is an example of the...
Sens. Durbin and Braun call on FDA to update its prescription ad guidance to reflect the explosion in social media and to prioritize protecting childr...
