Tag: Drug Approvals
FDA Approves Omvoh for Moderately to Severely Active Crohn Disease
Approval based on results from phase 3 VIVID-1 trial, in which end points of clinical remission and endoscopic response were met at one year
FDA Approves Gemtesa for Overactive Bladder in Men With BPH
Gemtesa approved for men with overactive bladder symptoms receiving pharmacologic treatment for benign prostatic hyperplasia
FDA Approves Ryoncil for Steroid-Refractory Acute Graft-Versus-Host After Allo-HSCT
Ryoncil is first FDA-approved mesenchymal stromal cell therapy for pediatric patients aged 2 months or older
FDA Approves Tryngolza as Adjunct to Diet for Familial Chylomicronemia Syndrome
Tryngolza significantly and substantially reduces triglyceride levels in adults with familial chylomicronemia syndrome
FDA Expands Approval of Vtama to Include Atopic Dermatitis
The nonsteroidal topical treatment is approved for patients 2 years and older
FDA Approves Nemluvio for Moderate-to-Severe Atopic Dermatitis
The monoclonal antibody treatment is for patients ages 12 years and older
FDA Approves Kebilidi for Aromatic L-Amino Acid Decarboxylase Deficiency
Approval represents first gene therapy for treatment of AADC deficiency
FDA Approves Bimzelx for Hidradenitis Suppurativa
Approval based on phase 3 trials showing clinical response at 16 weeks, with sustained benefit at 48 weeks
FDA Approves Cobenfy for Adults With Schizophrenia
Approval marks first new class of treatment in decades and the first muscarinic agonist
FDA Approves Emrosi for Rosacea in Adults
Phase 3 trials show significant reduction in total lesion count versus Oracea and placebo
