United States Food and Drug Administration
FDA Rejects Milestone Pharmaceuticals’ Etripamil Nasal Spray for PSVT
Etripamil, Cardamyst, PSVT, FDA rejection, Complete Response Letter, manufacturing issues, Milestone Pharmaceuticals
FDA to Decide on Merck’s Subcutaneous Keytruda in September 2025
Subcutaneous Keytruda, FDA decision, September 23, 2025, Merck & Co., cancer treatment, PDUFA date
Equillium’s pivotal GvHD study of anti-CD6 antibody comes up short
United States Food and Drug Administration, itolizumab, In complete remission, day, Equillium
FDAs policy, communications staff likely to be among agencys 3,500 staff cuts
Policy, Communication, Staff, United States Food and Drug Administration, CHARGE Syndrome
Soleno breaks through with FDA nod for Prader-Willi syndrome treatment Vykat XR
FDA approval, Vykat XR, Prader-Willi syndrome, hyperphagia, Soleno Therapeutics, diazoxide choline
FDA clears Exelixis’ TKI for neuroendocrine tumours
CABOMETYX, cabozantinib, neuroendocrine tumors, FDA approval, Exelixis, tyrosine kinase inhibitor
Wave Life Sciences’ WVE-N531 Shows Promise in Duchenne Muscular Dystrophy Treatment
Duchenne muscular dystrophy (DMD), WVE-N531, exon 53 skipping, Phase II trial, dystrophin expression, muscle health improvement, FDA approval
Senate confirms Johns Hopkins surgeon Marty Makary to lead FDA amid turbulence at the agency
Makary, Senate, United States Food and Drug Administration, Surgeon, Johns, Agencies, Dr., Marty
FDA Approves Blujepa: First New Oral Antibiotic for Uncomplicated UTIs in Nearly 30 Years
Gepotidacin, Blujepa, GSK, uncomplicated urinary tract infections (uUTIs), FDA approval, first-in-class antibiotic
DOGE Reverses Course on FDA Facility Closures, Including Major St. Louis Quality Lab
DOGE, FDA, lease terminations, St. Louis, drug quality lab, cost-cutting, reversal