Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
Urges Innovators to produce quality products that can be deployed at scale
Investment enables development of revolutionary multi-omic platform using super-resolution imaging technology for earlier disease detection and accelerated discovery of therapeutics
Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.
Chinook Therapeutics is a clinical-stage biopharmaceutical company with two high-value, late-stage assets in development for IgA nephropathy (IgAN), a rare, progressive chronic kidney disease
The new API plant is set up to meet all domestic and international regulatory standards and will manufacture niche molecules that have a global requirement
Agreement provides customers in the majority of Europe* access to supply through Univar Solutions distribution network
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time
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