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...
FDA seeks comments on the use of its Integrated Review document as it decides to expand its use beyond new molecular entities, original BLAs, and sele...
FDA publishes the eighth revision of a guidance on providing regulatory submissions for certain drug products in electronic format.
