FDA Approves Joenja (leniolisib) for the Treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)
LEIDEN, The Netherlands, March 24, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that the US Food and Dr
FDA Approves Zynyz (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC)
WILMINGTON, Del.--(BUSINESS WIRE)--Mar. 22, 2023 -- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz (retifanlimab-dlwr), a humanized monoclonal
FDA Approves Rezzayo (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis
SAN DIEGO & PARSIPPANY, N.J.--(BUSINESS WIRE)-- March 22, 2023 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration
FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome
SAN DIEGO–(BUSINESS WIRE)–Mar. 10, 2023 -- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has approved Daybue (trofinetide) for the treatme
FDA Approves Zavzpret (zavegepant) Nasal Spray for the Acute Treatment of Migraine
NEW YORK--(BUSINESS WIRE) March 10, 2023 -- Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved Zavzpret (zavegepant), the first and only calcitonin gene-r
FDA Approves Skyclarys (omaveloxolone) for the Treatment of Friedreich’s Ataxia
PLANO, Texas--(BUSINESS WIRE) February 28, 2023 -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a biopharmaceutical company focused on developing and comm
FDA Approves Altuviiio ([Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl]) Once-Weekly VIII Therapy for Hemophilia A
Paris and Stockholm – February 23, 2023 – The U.S. Food and Drug Administration (FDA) has approved Altuviiio™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referre
FDA Grants Accelerated Approval to Filspari (sparsentan) for the Reduction of Proteinuria in IgA Nephropathy
First single molecule Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for use in patients with IgA nephropathy (IgAN) Interim results from the ongoing Phase 3 PROTECT head-to-head tri
FDA Approves Syfovre (pegcetacoplan injection) for the Treatment of Geographic Atrophy, a Leading Cause of Blindness
WALTHAM, Mass., Feb. 17, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the U.S. Food and Drug
FDA Approves Lamzede (velmanase alfa-tycv) for the Treatment of Alpha-Mannosidosis
First and only enzyme replacement therapy for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients Ultra-rare progressive disease presents w
FDA Approves Jesduvroq (daprodustat) for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis
February 01, 2023 -- Today, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chroni
FDA Approves Jaypirca (pirtobrutinib) for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma
Jaypirca is the first BTK inhibitor of any kind specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor In the BRUIN Phase 1/2 trial, covalent BTK
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