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Lupin Gains FDA Approval for Generic Colonoscopy Prep Drug with 180-Day First-to-File Exclusivity
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AstraZeneca Gains FDA Approval for Imfinzi Combination Regimen in Bladder Cancer

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Lupin Gains FDA Approval for Generic Colonoscopy Prep Drug with 180-Day First-to-File Exclusivity

Lupin secures FDA ANDA approval for a generic colonoscopy prep drug, earning 180-day first-to-file exclusivity in the U.S. generics market.

Pharma Now Editorial Team

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AstraZeneca Gains FDA Approval for Imfinzi Combination Regimen in Bladder Cancer

AstraZeneca's Imfinzi combination wins FDA approval in bladder cancer, backed by a 60.7-month efficacy dataset with GMP and process validation implications.

Pharma Now Editorial Team

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Merck Gains FDA Breakthrough Therapy Designation for Calderasib in KRAS G12C Lung Cancer

Merck's calderasib receives FDA Breakthrough Therapy designation in KRAS G12C lung cancer, accelerating CMC and manufacturing readiness timelines.

Pharma Now Editorial Team

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AstraZeneca Reports Mixed Phase III Results for Anselamimab in Cardiac AL Amyloidosis Trial

AstraZeneca's Phase III anselamimab trial in cardiac AL amyloidosis returns mixed results, raising manufacturing and regulatory contingency questions.

Pharma Now Editorial Team

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