Press "Enter" to skip to content

Takeda Receives Complete Response Letter from the U.S. FDA for TAK-721

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.[1]

The CRL indicates the FDA has completed its review of the TAK-721 NDA and determined that it cannot be approved i…


– 출처 : https://www.newswire.co.kr/newsRead.php?no=937009&sourceType=rss