Imfinzi’s perioperative approval comes after both the FDA’s staffers and a panel of external experts expressed concerns about overtreatment when using the PD-L1 blocker both before and after surgery.
The agency raised its risk assessment for sporadic cases of mpox clade I in Europe to moderate on Friday.
“Children and adolescents are disproportionally affected by mpox in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden the access to vaccines and therapies for this vulnerable population,” Bavarian CEO Paul Chaplin said in a statement.
Lykos Therapeutics will lay off 75% of its workforce, or about 100 employees, and founder Rick Doblin will leave the board, the company said on Thursday, days after the U.S. FDA declined approval for its MDMA-based PTSD treatment.
Global health officials on Thursday confirmed an infection with a new strain of the mpox virus in Sweden and linked it to a growing outbreak in Africa, the first sign of its spread outside the continent a day after the World Health Organization declared the disease a global public health emergency.
Nearly two weeks ahead of its target action date, the regulator on Wednesday has signed off on Incyte and Syndax’s Niktimvo for the third-line treatment of graft-versus-host disease.