Massachusetts General Hospital researchers say FDA policy deviations for regulatory laboratory-developed tests during the Covid-19 pandemic give a clu...
FDA says changes to the clozapine REMS to ensure that the drugs benefits outweigh the risk of severe neutropenia take effect 11/15.
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Federal Register notice: FDA makes available a revised draft guidance for industry entitled Draft Guidance for Ferric Oxyhydroxide.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.