Federal Register notice: FDA makes available a draft guidance entitled Development of Non-Opioid Analgesics for Acute Pain.
The Axinn law firm asks FDA to put conditions on any approval of Injectafer sNDAs based on three clinical trials the firm says have significant defici...
Federal Register notice: FDA posts a notice that biosimilar BLA applicant Alvotech has notified the agency that it has been sued for patent infringeme...
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.