FDA asks Verrica for additional CMC information on its VP-102 NDA intended to treat molluscum contagiosum.
FDA signs a contract with TriNetX to expand its use of the platforms real-world data in the Sentinel program.
FDA issues four draft guidances to help facilitate the development of new animal drug products.
FDA issues CytoDyn a refusal to file letter on its BLA for leronlimab (PRO 140), a CCR5 antagonist used in combination therapy with highly active anti...
FDA releases an FDA-483 with eight inspection observations from an inspection at RC Outsourcing.
FDA grants Revamp Medical a breakthrough device designation for its Doraya percutaneous device for treating acute heart failure.
Federal Register notice: FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Viru...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Cartiva, a device used for treatment patients w...