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Zydus Secures FDA Priority Review for Saroglitazar NDA in Primary Biliary Cholangitis with November 2026 PDUFA Date
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Samsung Bioepis Launches Aflibercept Biosimilar OPUVIZ Across European Markets

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Zydus Secures FDA Priority Review for Saroglitazar NDA in Primary Biliary Cholangitis with November 2026 PDUFA Date

FDA grants Zydus priority review for saroglitazar NDA in PBC, setting a November 27, 2026 PDUFA date on Phase 3 EPICS-III data.

Pharma Now Editorial Team

Pharma Now

Samsung Bioepis Launches Aflibercept Biosimilar OPUVIZ Across European Markets

Samsung Bioepis launches OPUVIZ, its aflibercept biosimilar referencing Eylea, as its fifth directly commercialized biosimilar across European markets.

Pharma Now Editorial Team

Pharma Now

Sanofi Launches AccelRare AI Diagnostic Tool in India Following Class A Medical Device Classification

Sanofi's AccelRare receives Class A medical device classification in India, setting a regulatory reference point for AI pre-diagnostic tools in emerging markets.

Pharma Now Editorial Team

Pharma Now

AstraZeneca Secures 11 CDSCO Approvals in FY26 as India Revenue Reaches Rs. 22.76 Billion

AstraZeneca secured 11 CDSCO approvals in FY26 as India revenue rose 33% YoY to Rs. 22.76 billion, with oncology contributing Rs. 16.1 billion.

Pharma Now Editorial Team

Pharma Now