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May 31, 2024
FOSTER CITY (dpa-AFX) - Gilead Sciences Inc. (GILD) said that the confirmatory Phase 3 TROPiCS-04 study of Trodelvy in locally advanced or metastatic urothelial cancer did not meet the primary
May 29, 2024
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May 29, 2024
FDA approved Bkemv as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH); and atypical hemolytic uremic syndrome (aHUS).
May 29, 2024
/PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced the Prior...
May 29, 2024
The FDA has approved Amgen's Bkemv as the first interchangeable biosimilar to AstraZeneca's Soliris for treating rare diseases.
May 29, 2024
Tuesday, the FDA approved Amgen Inc (NASDAQ:AMGN) Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca Plc’s (NASDAQ:AZN) Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are also currently approved for Soliris: The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit compleme...
May 29, 2024
The approval was supported by data from the double-blind, active-controlled, 2-period crossover, phase 3 DAHLIA study.
May 28, 2024
NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders,
May 28, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab)...
May 23, 2024
NEW YORK, May 23, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders,