FDA clears an Apple 510(k) for its Apple Watch to be used as an over-the-counter device for assessing the risk of sleep apnea.
Boehringer Ingelheim plans an NDA for nerandomilast for treating idiopathic pulmonary fibrosis (IPF) after reporting that its Phase 3 FIBRONEER-IPF st...
Fresenius Kabi recalls (Class 1) one lot of the Ivenix Large Volume Pump primary administration sets after documenting a manufacturing defect.
FDA removes a partial clinical hold on Zentalis Pharmaceuticals azenosertib studies into the drugs use against solid tumors and two cancer types.
Federal Register notice: FDA announces its support for Electronic Common Technical Document Version 4.0 (v4.0)-based electronic submissions for CDER/C...
FDA approves a subcutaneous injectable formulation of Genentechs Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for all the adult indications...
Federal Register notice: FDA corrects a notice that appeared in the 6/21 Federal Register announcing the approval withdrawal 20 ANDAs.
FDA grants expanded approval for Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) as an add-on maintenance treatment for adolescent patients...
