This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
N-nitroso dimethylamine (NDMA) is a probable human carcinogen and tts effects on humans rely on observational studies.
Clinical studies are expected to start in Q2 2023.
Projected ~US$100 million cash balance of combined company expected to fund operations through mid-2025 and to clinical data over the next 12 to 24 months
More than 5 lakh patients availed the benefit of queue-less OPD registration using this service
The marketing authorisations for three generic drugs signifying advances in cancer treatment will considerably benefit thousands of patients by improving access, ensuring affordability
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
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