After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer ...

VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive TOKYO, Oct. 18 ...

FDA also approved the Ventana CLDN18 (43-14A) RxDx Assay, from Ventana Medical Systems, Inc. and Roche Diagnostics, to ...

Roche Holdings said it received Food and Drug Administration approval for its companion diagnostic of gastric and gastroesophageal junction cancer.

Astellas Pharma's drug Vyloy was approved for treatment of advanced gastric and gastroesophageal junction cancer by the Food and Drug Administration.

Astellas Pharma Inc. (ALPMY, ALPMY) said that the U.S. Food and Drug Administration has approved VYLOY (zolbetuximab-clzb) in ...

Following a sensational five-day spectacle which witnessed the entire technology community coverage and connect in a united international effort to forge the ...

Edifier International, the award-winning audio electronics designer, announces the MR3 2.0 monitor speaker system featuring Hi-Res audio certification, a flat frequency response from 52Hz to 40kHz and ...

Vyloy is the first CLDN18.2-targeted treatment to reach the US market alongside Roche's Ventana CLDN18 RxDx Assay for identifying eligible patients.

The FDA has already made more than a dozen cancer drug approval decisions this year and more expected in the next several ...