FDA sends Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (pacritinib) because ...
FDA moves to blunt criticism of the Commissioners National Priority Voucher Program with a news release containing 18 questions and answers, making th...
A Washington Post opinion article takes issue with FDAs recent decision to reject a low-dose atropine treatment for pediatric myopia despite a large c...
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 and industry representatives report agreement on several issues in the 1/21 MDUFA 6 negotiating session.
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 approves changes to the isotretinoin REMS to take effect in 180 days.
