CMS Coverage Decision of Pulmonary Embolectomy Criticized

November 19, 2021

JAMA Internal Medicine editor and a UCSF colleague wrote in a New England Journ of Medicine opinion piece that the decision highlights the need to establish a new requirement that would make coverage decisions contingent on evidence of benefit for Medicare population.

FDA Updates: Genentech Withdraws Tecentriq Indication; New Approvals for Xarelto, Tibsovo

August 28, 2021

Tecentriq loses indication, Xarelto is approved for reduce risks of cardiovascular events, Tibsovo is approved for rare cancer, Skytrofa is a new, once-weekly growth hormone, and supplemental application is filed Orencia graft-versus-host disease.

FDA Update: Keytruda and Aduhelm News Leads the Week

July 10, 2021

Keytruda loses one indication but gains another, Biogen narrows use of Aduhelm, Padcev gets regular approval and expanded indication, Amgen submits application for asthma biologic, agency issues complete response letter for diabetes prevention therapy teplizumab, Novartis resubmits NDA for inclisiran.