TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population
This case is an isolated case, similar to the earlier 30 cases reported in India from July 2022 onwards
Wanbury receives CEP approval from EDQM for launch of Dextromethorphan API
Agreement further expands Aptar Pharma’s leading respiratory portfolio
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
Lilly will license certain baricitinib manufacturing know-how to enable EVA Pharma to manufacture and supply treatment for various immunological diseases
Objective response rate of 54.8% seen with Daiichi Sankyo and Merck’s ifinatamab deruxtecan at 12 mg/kg dose in pretreated patients
This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II
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The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
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