FDA Grants Accelerated Approval for Rezdiffra (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

CONSHOHOCKEN, Pa., March 14, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatiti

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FDA Approves Tevimbra (tislelizumab-jsgr) for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Dr

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FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to Actemra

March 7, 2024 -- Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditio

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FDA Approves Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Prolia

Basel, March 5, 2024 -- Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Jubbonti, (denosumab-bbdz), an interchang

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FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva

Basel, March 5, 2024 -- Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an interchangeabl

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FDA Approves Letybo (letibotulinumtoxinA-wlbg) for the Treatment of Glabellar Lines

NEWPORT BEACH, Calif., March 4, 2024 /PRNewswire/ -- Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, today announced it received United States (U.S.)

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FDA Approves Simlandi (adalimumab-ryvk), an Interchangeable Biosimilar to to Humira

REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEV

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FDA Grants Accelerated Approval for Amtagvi (lifileucel) for the Treatment of Advanced Melanoma

SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infi

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FDA Approves Aurlumyn (iloprost) as the First Medication to Treat Severe Frostbite

February 14, 2024 -- The U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. "This approva

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FDA Approves Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis

OSAKA, Japan and CAMBRIDGE, Massachusetts, February 12, 2024 -- Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Eohilia (budesonide oral suspen

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FDA Approves Zelsuvmi (berdazimer topical gel) for the Treatment of Molluscum Contagiosum

SAN DIEGO--(BUSINESS WIRE) January 5, 2024 -- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that the U.S. Food and Drug Administration (FDA) has approved Zelsuvmi™ (berdazimer top

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FDA Approves Wainua (eplontersen) for the Treatment of Adults with Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

U.S. FDA approval based on Phase 3 NEURO-TTRansform results showing Wainua demonstrated consistent and sustained benefit halting neuropathy disease progression and improving neuropathy impairment and

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