Moderna says an analysis of a Phase 3 study of its Covid-19 mRNA vaccine supports the usefulness of a booster shot.
Federal Register notice: FDA makes available a revised draft guidance for industry entitled Draft Guidance for Ferric Oxyhydroxide.
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.