Alexion Pharmaceuticals Inc. gained expansion from the FDA of the label for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) ...
Alexion Pharmaceuticals, Inc. ALXN announced that it has filed regulatory applications with the FDA as well as the European Medicines Agency (EMA) seeking approval for a label expansion of Soliris.
The U.S. product label for Soliris also includes a boxed warning: "Soliris increases the risk of meningococcal infections. Vaccinate patients with a meningococcal vaccine at least two weeks prior to ...
Approval of Alexion Pharmaceutical Inc.'s Soliris (eculizumab) injection to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive ...
Alexion nabs potential $1B indication for Soliris, but it'll have to take on Roche's cheaper Rituxan
In an effort to protect its blockbuster Soliris, Alexion has employed a double strategy of nabbing additional approvals and positioning follow-up drug Ultomiris to switch over sales. Alexion added ...
Treatment with Soliris should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. The U.S. product label for ...
Genentech has shared longer-term phase 3 safety data on its anti-IL-6 antibody satralizumab, adding to the evidence in support of the drug ahead of a FDA decision to approve it in a rare disease ...
(Reuters) - The U.S. patent office will review patents on Alexion Pharmaceuticals Inc's blood disorder treatment Soliris, after Amgen Inc challenged them, court filings showed on Friday. The move ...
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