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Approval Launch
News filed under Approval/Launch, newest first.
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Ionis’ Tryngolza Receives Positive EMA Committee Opinion for Severe Hypertriglyceridemia
CHMP recommendation follows Phase 3 results showing up to 72% triglyceride reduction and an 85% redu...
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FDA Approves Viatris’ RYZUMVI for Presbyopia Treatment in Adults
The expanded U.S. indication adds presbyopia to RYZUMVI’s existing approval for pharmacologica...
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FDA Approves Bayer’s Kerendia for Chronic Kidney Disease Linked to Type 1 Diabetes
Bayer has announced that the U.S. Food and Drug Administration (FDA) has approved Kerendia (finereno...
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Glenmark Launches Calcium Gluconate Injection in the U.S., Expanding Its Hospital Injectable Portfolio
New Injectable Product Targets the U.S. Institutional Healthcare Market Glenmark Pharmaceuticals...
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Ultragenyx Gets FDA Accelerated Approval for Genglycos Gene Therapy in GSDIa
First Approved Therapy From Ultragenyx Directly Targets the Root Cause of GSDIa Ultragenyx Pharma...
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