JPM23: Is GSK's 15-day accelerated approval withdrawal the new normal? Hear FDA...

cafead

Administrator
Staff member
  • cafead   Jan 12, 2023 at 09:22: PM
via In a surprising move, GSK recently pulled multiple myeloma therapy Blenrep off the U.S. market just 15 days after the drug flunked a confirmatory trial. The product pull came at the request of the FDA, and the company's speedy action prompted industry watchers to wonder if there's a new benchmark for removing indications under the agency's accelerated approval program.

article source