Merck’s Keytruda yields mixed results in phase 3 KEYNOTE-062 trial
In the monotherapy arm of the study, KEYTRUDA met a primary endpoint by demonstrating noninferiority to chemotherapy, the current standard of care, for overall survival (OS) in the
Sunshine Lake Pharma, Lannett and its wholly owned subsidiary Lanexa Biologics have received approval from the US Food and Drug Administration (FDA) for Langlara (insulin glargine-aldy), an interchangeable biosimilar of Lantus (insulin glargine).
This recall is due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in six lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs
Smart Pharma will operate Smart-ACT, a computational repurposed drug discovery, modeling and validation platform, which uses latest technology for systematic screening of existing approved drug molecules against certain
The 20-acre site will significantly expand Kite’s ability to manufacture a variety of chimeric antigen receptor T (CAR T) therapies, including Yescarta (axicabtagene ciloleucel), Kite’s first commercially available
HES is a rare and often incapacitating disorder with limited treatment options. The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to