FDA approves AstraZenecas Farxiga to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in ad...
Cue Health files a de novo submission seeking permission to market its Cue RSV Molecular Test for at-home and point-of-care use.
FDA removes a partial clinical hold against Salarius Pharmaceuticals and its Phase 1/2 clinical trial evaluating seclidemstat in patients with Ewing s...
FDA medical reviewers ask the FDA Pulmonary-Allergy Drug Advisory Committee to consider the adequacy of pharmacokinetic and pharmacodynamic data to su...
FDA removes a clinical hold against two Immuron trials of Travelan, an orally administered passive immunotherapy that prophylactically reduces the lik...
FDA grants Singlera Genomics a breakthrough device designation for its PDACatch assay, a DNA methylation-based liquid biopsy assay for detecting pancr...
FDA approves Eyenovias Mydcombi (tropicamide and phenylephrine HCl ophthalmic spray) for inducing mydriasis for diagnostic procedures.
FDA announces a 5/11-12 workshop entitled Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop.
