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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 complement-medi

The approval was supported by data from the double-blind, active-controlled, 2-period crossover, phase 3 DAHLIA study.

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,

/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab)...

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,