CDER denies an Acer Therapeutics appeal of a 6/2019 complete response letter on an NDA for Edsivo (celiprolol) for treating vascular Ehlers-Danlos syn...
Janssen Pharmaceutical files an NDA for ponesimod for treating adult patients with relapsing multiple sclerosis.
FDA warns Indias Cipla Limited about CGMP violations in its production of finished drugs.
FDA warns Gojo Industries its Purell Healthcare Advanced Hand Sanitizer product line is considered an unapproved new drug that cannot be marketed unde...
FDA publishes a draft guidance on using flow restrictors for oral liquid drug products to limit unintentional ingestion by children.
FDA warns Indias Windlas Healthcare Private Limited about CGMP violations in its manufacturing of finished drugs.
FDA postpones a 4/16 advisory committee meeting that was to review a TransMedics PMA for the TransMedics Organ Care System.
Federal Register notice: FDA withdraws approval of three NDAs from multiple holders because they repeatedly failed to file required annual reports.