FDA denies as inappropriate a citizen petition asking it to halt two Cassava Sciences simufilam trials and investigate concerns about the trials.
FDA approves for priority review a Sanofi sBLA for Dupixent to treat moderate-to-severe atopic dermatitis in children 6 months to 5 years old.
Researchers from Harvard Medical School and the Engelberg Foundation call on the U.S. government to exercise its legal rights to obtain drugs develope...
FDA grants Bayer a fast track designation for its investigational blood thinner asundexian (BAY2433334) its use as secondary prevention in patients wi...
Public Citizen asks FDA and the Drug Enforcement Administration to add gabapentin products to Schedule V of the Controlled Substances Act.
An FDA advisory committee votes 14 to 1 that Innovent Biologics and Eli Lillys China-developed me too checkpoint inhibitor sintilimab plus chemotherap...
A Massachusetts federal judge sentences the former national sales director for the defunct New England Compounding Center to time served for defraudin...
An Associated Press report says the nomination of Robert Califf to be FDA commissioner is in doubt due to opposition from both Democrats and Republica...