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...
FDA tells Novo Nordisk that a new direct-to-consumer television ad for the newly launched Wegovy (semaglutide) oral weight-loss pill contains claims t...
FDA issues Regenxbio a complete response letter on its BLA seeking accelerated approval for RGX-121 (clemidsogene lanparvovec), a one-time gene therap...
