Health Archive

CSOFT’s health sciences blog aims to provide a better understanding of complex diseases, and regulatory polices from conducting experiments to introducing new type of drugs into the market.

Home 9 Health 9 Archive

NDA Submitted by Antengene in South Korea

Antengene submitted yesterday (1/3) a New Drug Application (NDA) with Orphan Drug Designation (ODD) to South Korea’s regulatory body, the Ministry of Food and Drug Safety (MFDS), for ATG-010 (selinexor). The NDA is specifically for the approval of ATG-010 (selinexor)...

AstraZeneca Unlikely to Receive EUA Approval Until April

According to Operation Warp Speed Chief, Moncef Slaoui, the AstraZeneca and Oxford University vaccine may not receive the U.S. Food and Drug Administration’s Emergency Use Approval (EUA) until April, despite the UK's approval yesterday (12/30). Questions surrounding...

Walmart Sued for Prescription Opioid Sales

The Department of Justice sued Walmart yesterday (12/22) for inadequately screening for questionable prescriptions, ultimately fueling the nation’s opioid crisis. According to the lawsuit, Walmart’s understaffed pharmacies pressured employees to fill prescriptions...

FDA Approves First Prostate Cancer Hormone Treatment

Today (12/21) the U.S. Food and Drug Administration (FDA) approved the first oral treatment for prostate cancer, a disease that affects on average one in every nine men. Orgovyx, created by Myovant, was created to treat advanced prostate cancer cases by blocking the...