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.
Ghostine has served as CEO of Geneva-based Firmenich, the world's largest privately owned perfume and taste company, since 2014.
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
Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
Ayurveda is one of the most advanced sciences of its times
The new Beyfortus data are consistent with all data accumulated to date and confirm its strong profile
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