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 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...
