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Former FDA associate chief counsel and CDER policy advisor Eva A. Temkin joins Paul Hastings as chair of the firms FDA practice.[ Price : $8.95]
Vyaire Medical recalls its AirLife Adult Manual Resuscitator and oxygen reservoir bag due to out-of-specification components used ...[ Price : $8.95]
After receiving a 12/2023 FDA refuse-to-file letter, Milestone Pharmaceuticals now says it will resubmit the NDA in the second qua...[ Price : $8.95]
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions animal drug applications ap...[ Price : $8.95]
Boehringer Ingelheim reports data from its Phase 2 survodutide study showing that up to 83.0% of adults treated with the drug achi...[ Price : $8.95]
FDA approves Alvotech and Teva Pharmaceuticals Simlandi (adalimumab-ryvk) injection, an interchangeable biosimilar to AbbVies Humi...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Janssen Biotechs Rybrevant ...[ Price : $8.95]
FDA creates a new CARES Act Amount Information Reporting application for drug establishments to use when submitting (xxx insert, d...