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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

Stellar-3 is a randomized, double-blind and placebo-controlled trial, which assessed the safety and efficacy of selonsertib in patients with bridging fibrosis (F3) due to NASH. According to the

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 Israeli pharma came to the decision after a pre-specified futility analysis showed that fremanezumab was unlikely to meet the primary endpoint of a phase 3 trial in

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

The investment will help GSK to expand the production capacity of major components of the adjuvant system used in several of its vaccines such as Shingrix, which secured

Taltz met the primary and all key secondary endpoints in the late-stage trial, called COAST-X. The 52-week trial evaluated the safety and efficacy of the psoriatic arthritis drug