An independent panel to the U.S. Food and Drug Administration voted in favor of approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, saying the benefits of the treatment outweigh the risks.
The U.S. Food and Drug Administration will review GlaxoSmithKline’s experimental treatment for multiple myeloma, a common form of blood cancer, for a reported side effect which affects the eyes of patients.
Indianapolis-based Eli Lilly announced the FDA’s Oncologic Drugs Advisory Committee voted 6-5 in favor of Cyramza (ramucirumab) plus erlotinib as a potential treatment for patients with untreated metastatic EGFR-positive non-small cell lung cancer (NSCLC).
The U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) generated an evenly split vote on whether to recommend approval of Durect Corporation’s Posimir.
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.
Intra-Cellular Therapies shares fell after the company announced that the FDA canceled the advisory committee meeting to discuss the New Drug Application for the schizophrenia drug lumateperone.
Independent experts of an FDA advisory panel voted in favor of the not-for-profit TB Alliance’s treatment for drug resistant tuberculosis, as a part of a three-drug combination regimen.
Independent experts on an advisory panel to the U.S. Food and Drug Administration voted against Daiichi Sankyo Co. Ltd.’s treatment for adults with a type of acute myeloid leukemia.
As America continues to grapple with the opioid crisis, nonprofit advocacy group Public Citizen is calling for the U.S. Food and Drug Administration (FDA) to place a moratorium on the approval of any new opioid medications.