The drugmaker’s Keytruda therapy in combination with chemotherapy was being evaluated in about 1,095 patients with high-risk endometrial cancer after surgery.
The recommendation is based on concerns that the company has not sufficiently addressed the problems and risks with the recalled devices.
Sarepta Therapeutics is anticipating full FDA approval and a label expansion for its gene therapy, Elevidys, with the company indicating on its Q1 earnings call last week that a draft label is imminent. But the therapy has come under the microscope regarding its high cost and clinical effectiveness.
Monthly medication subscription to the retailer’s virtual healthcare platform, Whole Health Rx, starts at an introductory price of $219, and does not require insurance, the company said in a statement.
Pfizer’s investigational Duchenne muscular dystrophy gene therapy fordadistrogene movaparvovec has been hit with another patient death, forcing the pharma to pause dosing in its Phase III study.
AstraZeneca announced that it will voluntarily pull Vaxzevria from the global market amid a sharp decline in demand and following the company’s recent admission that its vaccine is linked with a rare side effect.