Former FDA associate chief counsel and CDER policy advisor Eva A. Temkin joins Paul Hastings as chair of the firms FDA practice.
Vyaire Medical recalls its AirLife Adult Manual Resuscitator and oxygen reservoir bag due to out-of-specification components used in manufacturing.
After receiving a 12/2023 FDA refuse-to-file letter, Milestone Pharmaceuticals now says it will resubmit the NDA in the second quarter for etripamil n...
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions animal drug applications approved during the fo...
Boehringer Ingelheim reports data from its Phase 2 survodutide study showing that up to 83.0% of adults treated with the drug achieved a statistically...
FDA approves Alvotech and Teva Pharmaceuticals Simlandi (adalimumab-ryvk) injection, an interchangeable biosimilar to AbbVies Humira.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Janssen Biotechs Rybrevant (amivantamab-vmjw).
FDA creates a new CARES Act Amount Information Reporting application for drug establishments to use when submitting (xxx insert, delete xxx) annual re...
