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NDA Submitted by Antengene in South Korea
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
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...

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