This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II
Winrevair is the first activin signaling inhibitor therapy for PAH approved in Europe
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
There is an urgent need for more therapeutic treatment options for patients with painful osteoarthritis
Additional data from APPRAISE ATP trial reinforce modular therapy approach
Outlook 2024 remains flat CER sales growth and CORE EBITDA margin of high 20s
Late-breaker Phase 3 STRIDE-10 trial presented as an oral presentation at European Society of Clinical Microbiology and Infectious Diseases
If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade
Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results
PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally
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