NDA News-CliniExpert

FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension

RARITAN, NJ, March 22, 2024 -- Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi® – a single-tablet combination of macitentan, an endothelin r

FDA Approves Duvyzat (givinostat) for Duchenne Muscular Dystrophy

MILAN--(BUSINESS WIRE) -- Mar 22, 2024 -- Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inh

FDA Approves Tryvio (aprocitentan) for the Combination Treatment of Resistant Hypertension

RADNOR, Pa., March 20, 2024 /PRNewswire/ -- Idorsia Pharmaceuticals U.S. Inc. announced today that the US Food and Drug Administration (FDA) has approved Tryvio™ (aprocitentan) for the treatment of hy

FDA Approves Lenmeldy (atidarsagene autotemcel) for Children with Metachromatic Leukodystrophy

TOKYO and LONDON and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients arou

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

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

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

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

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