The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union
Good momentum in commercial CDMO business
If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU
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
This transformation will enable GE HealthCare to build a strong foundation for business growth
CMOs showed an increasing reluctance to take on debt in 2022
To equip them with the latest knowledge and skills to handle patients coming to them in a better way
Subscribe To Our Newsletter & Stay Updated