STAT1d
Federal watchdog raises some concerns about the FDA’s accelerated approval program
The Office of Inspector General reviewed the FDA’s use of accelerated approval for 24 drugs, ultimately finding issues with ...
US FDA declines to approve Atara Biotherapeutics' cancer therapy
The U.S. Food and Drug Administration on Thursday declined to approve Atara Biotherapeutics' cancer therapy, chemically ...
FDA Finally Revokes FD&C Red No. 3 For Food And Drugs
The FDA revokes FD&C Red No. 3 authorization due to cancer concerns under the Delaney Clause, impacting food and drug ...
Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says
Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...
Targeted Oncology58m
FDA Approves Axatilimab for Chronic GVHD in New Vial Sizes
Axatilimab has gained FDA approval in 9 mg and 22 mg vials, expanding treatment options for patients with chronic GVHD after ...
Billed as nonaddictive, new pain pill could soon win FDA approval
A non-opioid painkiller from Vertex Pharmaceuticals could become a blockbuster, but questions remain on whether it will prove ...
BioSpace2d
5 Novel FDA Approvals Notched in 2024
Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming ...
Atara Shares Sink After FDA Stalls Cancer Treatment
Atara Biotherapeutics shares plunged after the FDA rejected its application to bring a blood cancer treatment to market. Shares of the biotechnology company were recently down 46.5% to $7.04. The ...
FDA bans Red Dye No. 3, artificial coloring used in beverages, candy and other foods
The Food and Drug Administration said Wednesday it’s banning the use of Red No. 3, a synthetic dye that gives food and drinks ...