FDA grants $2 million to Marker Therapeutics to support the treatment arm in a Phase 2 trial of its T-cell candidate to treat patients with acute myel...
The Alliance for Pharmacy Compounding calls on FDA to reject recommendations in a National Academies report and instead maintain patient access to com...
Federal Register notice: FDA makes available a draft guidance entitled Computer Software Assurance for Production and Quality System Software.
FDA publishes a final rule setting a new deadline for the annual summary report required under the Right to Try Law.
The International Society for Cell & Gene Therapy says a federal court decision that FDA cannot regulate cell therapy products as drugs is flawed.
FDA launches a new Web page to highlight CDER Office of New Drugs regulatory science research activities.
Federal Register notice: FDA withdraws approval of a Merck NDA for arthritis drug Vioxx (rofecoxib).
An FDA report says generic drug approvals in 2018-2020 led to billions of dollars in savings.
