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...
FDA rejects an Oncopeptides appeal seeking to stop a CBER request for the company to voluntarily withdraw its accelerated-approved multiple myeloma dr...
New York attorney general Letitia James urges FDA to take further safety actions to address the dangers of Mercks Singilair (montelukast) and generics...
