NDA News-CliniExpert

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

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.)

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

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

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

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

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

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

FDA Approves Filsuvez (birch triterpenes) Topical Gel for the Treatment of Epidermolysis Bullosa

BOSTON, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare disease

FDA Approves Alyglo (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)

YOGIN, South Korea, Dec. 17, 2023 /PRNewswire/ -- GC Biopharma Corp (006280.KS) today announces that the US Food and Drug Administration (FDA) has approved Alyglo (immune globulin intravenous, human-s

FDA Approves Iwilfin (eflornithine) as Maintenance Therapy for High-Risk Neuroblastoma

LOUISVILLE, Ky.--(BUSINESS WIRE) --USWM, LLC (US WorldMeds) today announced that the U.S. Food and Drug Administration (FDA) has approved Iwilfin ™ (eflornithine) 192 mg tablets, a groundbreaking oral

FDA Approves iDose TR (travoprost intracameral implant) for the Treatment of Glaucoma

ALISO VIEJO, Calif.--(BUSINESS WIRE) December 14, 2023 -- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of