Federal Register notice: FDA seeks comments on an information collection revision entitled Biosimilars User Fee Program.
AbbVie files a supplemental BLA for Rinvoq (upadacitinib) for treating certain adults with moderately to severely active ulcerative colitis.
FDA approves Takedas Exkivity to treat specified non-small cell lung cancer patients identified that an approved diagnostic test.
FDA says it has consolidated two ICH guidances and retitled them Q2(R1) Validation of Analytical Procedures: Text and Methodology.
FDA releases a quiz that participants can use to determine how much they know about prescription drug promotion and the Bad Ad program.
FDA says Biomea Fusion can start a Phase 1 trial of its BMF-219 in some leukemia patients.
FDA clears a Gynesonics 510(k) for the (XXXX DELETE XXX) Sonata System 2.2 for treating fibroids.
FDA expands an Eli Lilly emergency use authorization for bamlanivimab 700 mg and etesevimab 1,400 mg administered together to provide post-exposure pr...