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Parexel Acquires Vitrana to Expand AI-Driven Pharmacovigilance and Patient Safety Capabilities
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CARBOGEN AMCIS Shanghai Site Clears Unannounced NMPA GMP Inspection

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Parexel Acquires Vitrana to Expand AI-Driven Pharmacovigilance and Patient Safety Capabilities

Parexel acquires Vitrana to integrate AI-driven pharmacovigilance, reshaping safety reporting workflows for pharma manufacturers and CRO partners.

Pharma Now Editorial Team

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CARBOGEN AMCIS Shanghai Site Clears Unannounced NMPA GMP Inspection

CARBOGEN AMCIS Shanghai clears an unannounced NMPA GMP inspection, signalling sustained compliance under China's tightening regulatory oversight.

Pharma Now Editorial Team

Pharma Now

Mineralys Therapeutics Gains FDA NDA Acceptance for Lorundrostat with December 2026 PDUFA Date

FDA accepts Mineralys NDA for lorundrostat with a December 22, 2026 PDUFA date, triggering pre-approval manufacturing and CMC readiness requirements.

Pharma Now Editorial Team

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Ascendis Pharma Achieves Two-Year Pivotal Data for TransCon CNP in Achondroplasia Ahead of NDA Positioning

Ascendis Pharma's two-year ApproaCH Trial data for navepegritide show sustained AGV gains and a clean safety record, advancing NDA readiness.

Pharma Now Editorial Team

Pharma Now