FDA Review posts product approval summaries for the week ending 8/2/2019.
Federal Register notice: FDA makes available a draft guidance entitled Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers....
Federal Register notice: FDA releases a final guidance on bacterial vaginosis drug development.
Federal Register notice: FDA makes available a draft guidance entitled General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and...
FDA clears a Medicrea Group 510(k) for its Tulip Genesis for use with the UNiD Adaptive Spine Intelligence platform technology.
FDA allows Momenta Pharmaceuticals to begin an adaptive Phase 2/3 clinical study for its FcRn inhibitor nipocalimab in warm autoimmune hemolytic anemi...
FDA approves a Daiichi Sankyo NDA for Turalio (pexidartinib) capsules for treating adult patients with symptomatic tenosynovial giant cell tumor.