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Pharma Now Editorial Team
Pharma Now Editorial Team
Pharma Now Editorial Team
Pharma Now Editorial Team
Pharma Now Editorial Team
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Lupin Gains FDA Approval for Generic Sutab Tablets with 180-Day Exclusivity
Lupin secures FDA approval for generic Sutab Tablets with 180-day first-filer exclusivity, starting a finite manufacturing and launch window.
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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.
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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.
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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.
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