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...
FDA approves an Eli Lilly BLA for Ebglyss (lebrikizumab-lbkz) for treating adults and children 12 years of age and older with moderate-to-severe atopi...
FDA clears a SamanTree Medical 510(k) for its Histolog Scanner for imaging the internal microstructure of tissues including identifying cells, vessels...
FDA approves Genentechs Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) twice-a-year subcutaneous injection for treating relapsing multiple sclero...
A group of bipartisan U.S. senators introduce the FDA Modernization Act 3.0, a bill to direct the agency to finally implement the FDA Modernization Ac...
