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.
FDA expands the emergency use authorization for Pfizer-BioNTechs Covid-19 vaccine to include adolescents aged 12 through 15 years.
FDA Review posts the Federal Register notices for the week ending 5/7/2021.
Federal Register notice: FDA announces that OMB has approved six information collections.
Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Product Communications That Are Consistent With th...