United States Food and Drug Administration
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
Novartis snags FDA nod for Fabhalta in another kidney disease but leaves room for rival Apellis
Fabhalta, United States Food and Drug Administration, Apellis, Novartis, Approved, C3 G, Proteinuria, pegcetacoplan, Kidney Diseases
J&J advances Stelara succession scheme with FDA nod for Tremfya in Crohn’s disease
Tremfya, United States Food and Drug Administration, Crohn ‘s disease, Approved, CD, J&J ‘s
Alnylam’s Amvuttra Approved for ATTR Cardiomyopathy, Challenging Pfizer and BridgeBio
Amvuttra, vutrisiran, ATTR-CM, FDA approval, RNAi therapeutic, cardiomyopathy
Trump blog: FDA, NIH picks clear Senate panel; FDA top lawyer resigns
United States Food and Drug Administration, NIH Mouse, Senate