Three people petition FDA to add information from the fluoroquinolone Boxed Warning to the top of the drugs Medication Guide as a way to better inform...
An FDA advisory committee votes 17 to 1 against approving a BrainStorm Cell Therapeutics BLA for NurOwn, an investigational mesenchymal stem cell ther...
FDA approves a subcutaneous administration for Takedas Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulce...
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 ...
