The U.S. Food & Drug Administration has granted orphan drug designation to Chicago-based Amphix Bio's treatment for acute ...

Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the ...

FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says By Annika Kim Constantino, CNBC • Published July 11, 2025 • Updated on July 11, 2025 at 8:30 am ...

The FDA halted the emergency use authorization of Evusheld because it does not appear to protect against Covid-19 from viral variants in U.S.