The submissions are supported by data from the Phase 3 KEYNOTE-905 trial
Glenmark’s Ropivacaine Hydrochloride Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug Naropin Injection of Fresenius Kabi USA
The acquisition centers on ImCheck’s lead Phase I/II program, ICT01, a first-in-class monoclonal antibody targeting BTN3A
Yesintek and Yesintek I.V. are approved for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients
Global Phase 3 MANEUVER study highlights ongoing benefits and consistent safety profile
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
XTANDI is the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in this patient population, supporting its earlier use in this setting
Contera Pharma will receive an upfront payment and full research funding for each target under investigation
The initial $100 million will fund a state-of-the-art hard-shell capsule facility in Atlanta
Results from the Phase 2 PHAROS trial potentially establish new benchmark with targeted combination therapies for this patient population
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