Tag: fda

ImmuCell Announces Strategic Focus on First Defense After Receiving an FDA Incomplete Letter for Re-Tain

December 24, 2025 13:05 ET  | Source: ImmuCell Corporation PORTLAND, Maine, Dec.…

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U.S. FDA Approves Agios AQVESME (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

AQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and…

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Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia

November 25, 2025 18:15 ET  | Source: Ascendis Pharma –  Prescription Drug…

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Ofirnoflast (HT-6184) Receives Orphan Drug Designation from U.S. FDA for Myelodysplastic Syndromes

LEHI, Utah, Oct. 23, 2025 /PRNewswire/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical…

FDA Approves Expanded Indication for UZEDY (risperidone) Extended-Release Injectable Suspension as a Treatment for Adults Living with Bipolar I Disorder

FDA approves UZEDY® (risperidone) extended-release injectable suspension for subcutaneous use as monotherapy…

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