FDA releases for public comment proposed revisions to an International Council for Harmonization guideline on elemental impurities.
FDA grants breakthrough device designation to Avenda Healths prostate cancer artificial intelligence-enabled focal therapy system.
AstraZeneca submits a BLA for tezepelumab, a potential first-in-class medicine for treating severe asthma.
FDA publishes an International Council for Harmonization final guidance on technical and regulatory considerations for postapproval management of drug...
FDA clears a Bolder Surgical 510(k) for an expanded indication for the CoolSeal Trinity 5 mm Laparoscopic Vessel Sealer, Divider, and Dissector to inc...
Bayer reports positive data from a second Phase 3 study that evaluated the safety and efficacy of finerenone versus placebo when added to standard of ...
Liquidia resubmits its NDA for LIQ861 for treating pulmonary arterial hypertension.
FDA posts two 2019 Form FDA-483s after inspecting two Hennepin County Medical Center clinical investigators who were cited for study violations.