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Lupin Gains FDA Establishment Inspection Report for Ankleshwar Facility Following Pre-Approval Inspection Closure
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Sanofi Gains FDA Priority Review for Venglustat in Gaucher Disease Type 3

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Lupin Gains FDA Establishment Inspection Report for Ankleshwar Facility Following Pre-Approval Inspection Closure

Lupin's Ankleshwar site receives FDA EIR after a product-specific pre-approval inspection in March 2026, clearing a key compliance checkpoint.

Pharma Now Editorial Team

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Sanofi Gains FDA Priority Review for Venglustat in Gaucher Disease Type 3

FDA grants Priority Review to Sanofi's venglustat NDA for Gaucher disease type 3, with a PDUFA date of 25 November 2026.

Pharma Now Editorial Team

Pharma Now

Novo Nordisk Presents Late-Stage Pipeline and Semaglutide Expansion Data at ADA 2026

Novo Nordisk's ADA 2026 data across semaglutide and GLP-1 pipeline programs signals near-term API and CDMO demand shifts.

Pharma Now Editorial Team

Pharma Now

Asahi Kasei Licenses DAR-Control ADC Platform to Advance Single- and Dual-Payload Conjugate Manufacturing

Asahi Kasei licenses a DAR-control ADC platform enabling precise payload attachment in single- and dual-payload conjugates, with direct implications for process validation and CMC filings.

Pharma Now Editorial Team

Pharma Now