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FDA Delays Final Approval of Novavax COVID Vaccine

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By I. Edwards HealthDay Reporter FRIDAY, April 4, 2025 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) has delayed the full approval of...

FDA Approves Qfitlia to Cut Bleeding Episodes in Patients With Hemophilia

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Subcutaneous injection cuts the amount of the protein antithrombin, leading to an increase in thrombin

FDA Approves Cabozantinib for Previously Treated Advanced Neuroendocrine Tumors

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Patients treated with cabozantinib survived significantly longer with no worsening of their disease compared with patients who received placebo

FDA Approves Blujepa for Uncomplicated Urinary Tract Infections

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Medication approved for uUTIs in women and pediatric patients aged 12 years and older

FDA OKs Amvuttra to Treat Heart Conditions

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By I. Edwards HealthDay Reporter MONDAY, March 24, 2025 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) has approved a new drug for...

FDA Approves Tremfya for Active Crohn Disease in Adults

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Tremfya is the first and only interleukin-23 inhibitor offering both subcutaneous and intravenous induction options for Crohn disease

FDA Approves TNKase for Acute Ischemic Stroke

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The five-second intravenous bolus offers faster, simpler administration than Activase

FDA Expands Indication of Dust Mite Allergy Drug to Include Young Children

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Odactra is an immunotherapy for treatment of house dust mite-induced allergic rhinitis

FDA Approves First Rapid-Acting Insulin Biosimilar for Patients With Diabetes

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Merilog administered subcutaneously five to 10 minutes before mealtime helps improve glycemic control

FDA Approves Tablet Form of Evrysdi for Spinal Muscular Atrophy

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Tablet shows same established efficacy and safety as the Evrysdi oral solution