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 sends Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (pacritinib) because ...
FDA warns Phoenix, AZ-based Signature Formulations about repeat CGMP violations in its manufacturing of finished drugs as a contract facility.
FDA cites Lonza Portsmouth for significant manufacturing and quality control deficiencies at its cell therapy facility where Vertex Pharmaceuticals an...
FDA issues two untitled letters to Argenx, alleging that separate direct-to-consumer television advertisements for Vyvgart Hytrulo overstate benefits,...
