FDA warns Mark Dacey of Denver, CO, about failing to obtain informed consent for two clinical investigations he conducted.
FDA and industry representatives report agreement on several issues in the 1/21 MDUFA 6 negotiating session.
FDA approves changes to the isotretinoin REMS to take effect in 180 days.
FDA issues a Warning Letter to Bio-Medical Pharmaceutical Manufacturing Corporation, citing widespread GMP violations at the companys Houston facility...
FDA accepts for priority review a Takeda NDA for TAK-861 (oveporexton) as a potential first-in-class treatment for narcolepsy Type 1.
FDA issues Moderna a refusal-to-file letter on its BLA for an investigational seasonal influenza vaccine mRNA-1010, despite the companys use of a Prio...
FDA issues two untitled letters to Argenx, alleging that separate direct-to-consumer television advertisements for Vyvgart Hytrulo overstate benefits,...
Aurobindo Pharma says that FDA has completed an inspection of wholly owned subsidiary Eugia Pharma Specialities in Pashamylaram, Telangana, India that...
