5:24 PM
Jun 20, 2019
 |  BC Extra  |  Company News

June 20 Company Quick Takes: Priority Review for Alexion, Melinta therapies; plus Alimera, Denovo and more

Priority Review for Alexion's Ultomiris sBLA
FDA accepted and granted Priority Review to an sBLA from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) for Ultomiris ravulizumab-cwvz to block complement-mediated thrombotic microangiopathy in patients with atypical hemolytic uremic syndrome. The sBLA's PDUFA date is Oct. 19. The news comes two days after Japan approved the long-acting C5 inhibitor for paroxysmal nocturnal hemoglobinuria.

Melinta leaps with Priority Review for Baxdela sNDA

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