The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023
KEYTRUDA plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone in these patients
The agreement extends the customer's suite of cloud DevOps, data engineering, and data platform management solutions
The newly launched Genomic Health Insights (GHI) program to make sequencing accessible to all
This product will be launched through Granules Consumer Health (GCH) division
SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Advances clinical research capabilities with leading regulatory grade registries platform
Cytel excels at using proven quantitative techniques to transform real-world data into actionable insights
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