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Glenmark Advances Phase 3 Trial of HER2-Targeted ADC for Platinum-Resistant Ovarian Cancer
Glenmark moves a HER2-targeted ADC into Phase 3 for platinum-resistant ovarian cancer, raising GMP and process validation considerations for ADC manufacturing at scale.
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Syngene Appoints Siddharth Mittal as MD and CEO Following Leadership Transition
Syngene names Siddharth Mittal MD and CEO; his 13-year CFO tenure at Biocon shapes expectations for CDMO capacity and partnership strategy.
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GlaxoSmithKline Gains FDA CBER Approval for Fluarix Seasonal Strain Update in March 2026
FDA CBER issued a March 2026 approval letter for GlaxoSmithKline's Fluarix, shifting the seasonal strain update timeline earlier than prior years.
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EMA Launches Women's Health Initiative Targeting Clinical Trial Design and Labelling Requirements
EMA formalises a women's health initiative across four workstreams, with clinical trial design and labelling obligations set for review ahead of a September workshop.
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