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...
Genentechs Phase 3 IMagyn050 study finds that the addition of Tecentriq (atezolizumab) to Avastin (bevacizumab), paclitaxel and carboplatin did not me...
Sens. Rubio and Warren introduce legislation to study the impact of foreign government investment in the U.S. drug supply chain.