Cover storyPharma Manufacturing Trends 2026: From Smart Factories To AI-Driven Production
Pharma manufacturing trends in 2026 reveal smart factories, real-time AI quality checks, and predictive maintenance reshaping drug production
Cover storyPharma manufacturing trends in 2026 reveal smart factories, real-time AI quality checks, and predictive maintenance reshaping drug production
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FDA grants accelerated approval to Tudriqev for anti-PD-1 refractory melanoma, raising immediate CMC and potency testing obligations for biologics manufacturers.

FDA issued a warning letter to Global Calcium Pvt. Limited after inspectors found falsified batch records and deleted electronic files at its Tamil Nadu API facility.

FDA closes Warning Letter 320-25-30 for Global Calcium Pvt. Limited, with future inspections set to assess sustainability of corrections.

FDA grants Replimune accelerated approval for Tudriqev plus nivolumab in PD-1-refractory unresectable melanoma, with confirmatory trials required.
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