Eyenovia decides to terminate its Phase 3 CHAPERONE study evaluating a drug-device combination of low-dose atropine as a potential treatment for pedia...
FDA approves a Syndax Pharmaceuticals NDA for Revuforj (revumenib), a menin inhibitor for treating relapsed or refractory acute leukemia.
HHS secretary-nominee Robert F. Kennedy Jr. vows to free the agencies, including FDA, from the smothering cloud of corporate capture.
FDA accepts for review a Sanofi and Regeneron supplemental BLA resubmission for Dupixent (dupilumab) for treating chronic spontaneous urticaria.
Federal Register notice: FDA makes available a draft guidance on nonclinical safety assessments for oligonucleotide drug products.
FDA approves an Atamyo Therapeutics IND for a Phase 1b/2b clinical trial involving its ATA-200 gene therapy for treating rare form of muscular dystrop...
FDA says it has granted breakthrough device designation to 1,041 devices from 2015 through the 9/30 end of the 2024 fiscal year.
FDA approves PTC Therapeutics Kibilidi as the first gene therapy to treat aromatic L-amino acid decarboxylase deficiency.
