Tag: fda

Novel Anti-Fibrotic Drug AK3280 Cleared by FDA to Initiate Phase 2 Proof-of-Concept Clinical Trial in IPF

SHANGHAI, Feb. 12, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio")…

Hemex Health Receives FDA Breakthrough Device Designation for Gazelle Hb Variant Test

PORTLAND, Ore., Feb. 06, 2026 (GLOBE NEWSWIRE) -- Hemex Health, a medical…

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Pharming Group receives Complete Response Letter from U.S. FDA for sNDA for Joenja (leniolisib) in children aged 4 to 11 years with APDS

Leiden, the Netherlands, February 1, 2026: Pharming Group (Euronext: PHARM; Nasdaq: PHAR)…

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QTX-2101 Awarded FDA Fast Track Designation for the Treatment of Acute Promyelocytic Leukemia

CHICAGO, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Quetzal Therapeutics, a biopharmaceutical company…

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Siren Biotechnology Announces FDA Clearance of First IND, Advancing Company to Clinical Stage

SAN FRANCISCO, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Siren Biotechnology, pioneers of…

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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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