FDA publishes a draft guidance on the electronic submission format for de novo medical device requests.
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...
