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FDA Approves More Broadly Protective Meningococcal Vaccine

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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

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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

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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

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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

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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

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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

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Tryngolza significantly and substantially reduces triglyceride levels in adults with familial chylomicronemia syndrome

FDA Expands Approval of Vtama to Include Atopic Dermatitis

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The nonsteroidal topical treatment is approved for patients 2 years and older

FDA Approves Nemluvio for Moderate-to-Severe Atopic Dermatitis

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The monoclonal antibody treatment is for patients ages 12 years and older

FDA Approves Kebilidi for Aromatic L-Amino Acid Decarboxylase Deficiency

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Approval represents first gene therapy for treatment of AADC deficiency