[ Price : $8.95]
FDA and industry representatives report agreement on several issues in the 1/21 MDUFA 6 negotiating session.[ Price : $8.95]
FDA approves changes to the isotretinoin REMS to take effect in 180 days.[ Price : $8.95]
FDA issues a Warning Letter to Bio-Medical Pharmaceutical Manufacturing Corporation, citing widespread GMP violations at the compa...[ Price : $8.95]
FDA accepts for priority review a Takeda NDA for TAK-861 (oveporexton) as a potential first-in-class treatment for narcolepsy Type...[ Price : $8.95]
FDA issues Moderna a refusal-to-file letter on its BLA for an investigational seasonal influenza vaccine mRNA-1010, despite the co...[ Price : $8.95]
FDA sends Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (...[ Price : $8.95]
FDA warns Phoenix, AZ-based Signature Formulations about repeat CGMP violations in its manufacturing of finished drugs as a contra...[ Price : $8.95]
FDA cites Lonza Portsmouth for significant manufacturing and quality control deficiencies at its cell therapy facility where Verte...