Federal Register notice: FDA seeks comments on an information collection extension entitled Adverse Experience Reporting For Licensed Biological Produ...
Federal Register notice: FDA seeks comments on an information collection revision entitled Applications for FDA Approval to Market a New Drug 21 CFR ...
FDA approves an Amicus Therapeutics NDA for Pombiliti (cipaglucosidase alfa-atga) in combination with Opfolda (miglustat) 65mg capsules for treating a...
According to Reuters, FDA says it is doing a thorough review of 265 reports of suicidal thoughts or behavior that may be associated with taking Novo N...
FDA publishes a guidance on technical considerations for medical devices that use physiologic closed-loop control technology with recommendations for ...
FDA publishes a draft guidance to assist sponsors in developing various types of products to prevent or treat graft-versus-host disease.
FDA approves a Fabre-Kramer Pharmaceuticals NDA for Exxua (gepirone hydrochloride extended-release tablets) for treating major depressive disorder in ...
FDA approves a new indication for Pfizers Bosulif to treat some pediatric patients with chronic myelogenous leukemia.
