Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
The order, part of an international framework agreement is to be executed between February to April, 2025
We are witnessing a steady and sustainable growth in the country as the Q2 revenue from operations increased by 31%
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities
AMR poses a critical threat to global public health undermining decades of progress made in the field of modern medicine
The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg
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