FDA issues a safety alert advising patients and healthcare providers about the potential risk of serious complications with Holigics BioZorb Marker an...
FDA researchers say a wide range of treatments for rare pediatric diseases have been developed in the 10 years since the pediatric disease priority re...
FDA accepts for review a BeiGene BLA for Tevimbra (tislelizumab) for combination use with chemotherapy in treating locally advanced unresectable or me...
FDA sends Minerva Neurosciences a complete response letter on its NDA for roluperidone, indicated for treating negative symptoms in patients with schi...
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...
