Decision on EU marketing authorisation for this population expected by September 2024
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Imfinzi also recommended for patients with mismatch repair deficient disease
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine
Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
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 on EU marketing authorisation expected for momelotinib by early 2024
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial
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