Tag: Drug Approvals
FDA Approves TNKase for Acute Ischemic Stroke
The five-second intravenous bolus offers faster, simpler administration than Activase
FDA Expands Indication of Dust Mite Allergy Drug to Include Young Children
Odactra is an immunotherapy for treatment of house dust mite-induced allergic rhinitis
FDA Approves First Rapid-Acting Insulin Biosimilar for Patients With Diabetes
Merilog administered subcutaneously five to 10 minutes before mealtime helps improve glycemic control
FDA Approves Tablet Form of Evrysdi for Spinal Muscular Atrophy
Tablet shows same established efficacy and safety as the Evrysdi oral solution
FDA Approves More Broadly Protective Meningococcal Vaccine
Vaccine helps protect against the A, B, C, W, and Y serogroups of Neisseria meningitidis
FDA Approves Symbravo for Acute Treatment of Migraine in Adults
Symbravo can rapidly eliminate migraine pain within two hours, with efficacy sustained through 24 and 48 hours, across migraine pain severity
FDA Approval Expands Earlier Use of Enhertu for Metastatic Breast Cancer
Approval is targeted for patients with HER2-low or HER2-ultralow metastatic breast cancer with disease progression after endocrine therapy
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
