FDA Approves Zevtera (ceftobiprole medocaril sodium) for Bacteremia, Skin and Skin Structure Infections, and Pneumonia

Allschwil, Switzerland, April 04, 2024 -- Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacteria

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FDA Approves Voydeya (danicopan) as Add-On Therapy for the Treatment of Extravascular Hemolysis in Paroxysmal Nocturnal Hemoglobinuria

April 1, 2024 -- Voydeya (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal h

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FDA Approves Risvan (risperidone) for the Treatment of Schizophrenia

Madrid -- 2 April, 2024 -- Today, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”) has announced that the U.S. Food and Drug Administration (FDA) has authorised the marketing of Risvan®

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FDA Approves Vafseo (vadadustat) for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis

CAMBRIDGE, Mass., March 27, 2024 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today

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FDA Approves Winrevair (sotatercept-csrk) a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension

RAHWAY, N.J.--(BUSINESS WIRE) March 26, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved s

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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

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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

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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

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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

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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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