A U.S. Food and Drug Administration committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.

The U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee voted to recommend approval of Shionogi & Co. Ltd.’s investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options.

An independent expert panel to the U.S. FDA recommended approval of GlaxoSmithKline Plc’s over-the-counter nicotine oral spray that aims to help smokers quit their addiction.

The U.S. FDA Oncologic Drugs Advisory Committee recommended approval of Pfizer’s proposed epoetin alfa biosimilar across all indications.