News

Tracking the latest developments from across the health sciences industry
Home 9 News
ALX Oncology: Evorpacept Receives ODD to Treat GC
ALX Oncology: Evorpacept Receives ODD to Treat GC

The U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) for ALX Oncology’s evorpacept, a next-generation CD47 blocker, to treat patients with gastric cancer and gastroesophageal junction cancer. Gastric cancer and gastroesophageal...

Pidnarulex: FDA Fast Track to Treat Solid Tumors
Pidnarulex: FDA Fast Track to Treat Solid Tumors

Senhwa Biosciences’ Pidnarulex (CX-5461) has been granted a Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of solid tumors with BRCA1/2, PALB2, and other gene mutations. In patients with solid tumors, specifically breast...

ABOUT US

CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com