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...
New York attorney general Letitia James urges FDA to take further safety actions to address the dangers of Mercks Singilair (montelukast) and generics...
BrainStorm Cell Therapeutics files a Special Protocol Assessment request for a Phase 3b study of NurOwn, its investigational treatment for amyotrophic...
FDA accepts for priority review a Sanofi and Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult p...
FDA issues Venatorx Pharmaceuticals and Melinta Therapeutics a complete response letter on their NDA for cefepime-taniborbactam, a beta-lactam/beta-la...
