This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
The primary objective was to evaluate safety and tolerability of Ropanicant in patients with MDD
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous
The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
The wP-IPV-based hexavalent vaccination is an innovative immunization alternative to the current pentavalent and standalone IPV vaccines
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
ALS patients experience neuroinflammation and rapid neurodegeneration
Konieczny has served as Interim CEO since April 2024
Phase 3 clinical trial designed to evaluate the safety and efficacy of tivozanib in combination with nivolumab
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