AbbVie bags major European label expansion for VENCLYXTO in chronic lymphocytic leukemia
The expanded indication is backed by data from the Phase 3 AMPLIFY and GLOW trials and the Phase 2 CAPTIVATE study,
The expanded indication is backed by data from the Phase 3 AMPLIFY and GLOW trials and the Phase 2 CAPTIVATE study,
The findings mark one of the longest progression-free survival outcomes ever reported in advanced lung cancer
The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market
The programme evaluated anselamimab as a first-line add-on to standard plasma cell dyscrasia therapy in patients with advanced cardiac AL amyloidosis
The study tracked patients for more than five years (median 60.7 months), with protection against disease returning emerging in under four months and continuing long term
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
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