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.
Qiagen recalls filter tips for use with the QIAsymphony SP/AS instruments due to their potential to leak and affect test results.
Teleflex recalls certain Sheridan endotracheal tubes and connectors, which are also used in Centurions convenience kits.
FDA issues a draft guidance with information for sponsors and nonclinical laboratory staff about the management and conduct of pathology peer review p...
FDA issues a draft guidance on testing and labeling medical devices for safety in the magnetic resonance environment.
FDA issues a final guidance on developing drugs to treat bacterial vaginosis.
Federal Register notice: FDA makes available a draft guidance entitled E8(R1) General Considerations for Clinical Studies.