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...
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.