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Roche RHHBY announced that the European Commission (EC) approved PiaSky (crovalimab) for treating patients suffering from paroxysmal nocturnal hemoglobinuria (PNH). PiaSky is a novel recycling ...
Credit: Novartis. The approval was based on data from the phase 3 APPLY-PNH trial. Health care providers who prescribe Fabhalta must enroll in the Fabhalta REMS. The Food and Drug Administration ...
PNH was once a rare disease with no approved therapeutic options. The market for PNH drugs is now growing crowded. Soliris’s 2007 approval made it the first therapy for the disorder.
Apellis Pharmaceuticals, Inc. APLS received the FDA approval for its targeted C3 therapy, Empaveli (pegcetacoplan), as a monotherapy treatment for adult patients suffering from paroxysmal ...
Subcutaneous C5 Inhibitor Approved for PNH — Longer-acting crovalimab designed for more sustained effect and less treatment burden by Ian Ingram , Managing Editor, MedPage Today June 24, 2024 ...
FDA accepts Alexion’s application for next-generation PNH drug Soliris, the drugmaker's cash cow approved for the same disease, faces biosimilar competition as patent expiry looms. By Alaric ...
Principal support for the approval came from the randomized phase III ALPHA trial, which evaluated standard treatment with or without danicopan in 73 patients with PNH and significant ...
Ravulizumab, a new drug for paroxysmal nocturnal hemoglobinuria (PNH), requires IV infusion only once every 8 weeks, compared with every 2 weeks for eculizumab, the only drug currently approved ...
Apellis Pharmaceuticals is gearing up for potential approval of its PNH drug pegcetacoplan; the PDUFA date has been established for May 14, 2021.
Apellis announces U.S. Food and Drug Administration (FDA) approval of Empaveli™ (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria (PNH). [ press release ]. Waltham, MA: Apellis ...
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