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.
A U.S. FDA advisory panel voted in favor of J&J’s experimental nasal spray esketamine, which has a compound similar to often-abused ketamine, bringing the drug closer to approval.
The U.S. FDA rejected marketing approval of Alkermes’ major depressive disorder treatment ALKS-5461.
An advisory panel to the U.S. Food and Drug Administration was divided over whether to recommend approval of a treatment for type 1 diabetes developed by Lexicon Pharmaceuticals Inc. and France’s Sanofi SA.
An FDA advisory panel voted against approving Alkermes Plc’s depression treatment ALKS 5461 in patients with an inadequate response to standard antidepressant therapies.
An advisory panel to the U.S. Food and Drug Administration voted unanimously in favor of Celltrion Pharm Inc.’s copycat drug of Roche Holding AG’s blood cancer drug Rituxan.
AcelRx Pharmaceuticals Inc.’s opioid painkiller offers no apparent advantage to currently available therapies, staff reviewers of the U.S. Food and Administration said.
Shares of Paratek Pharmaceuticals climbed in pre-market trading after the company announced a U.S. Food and Drug Administration advisory committee voted overwhelmingly in favor of intravenous and oral treatments for acute bacterial skin and skin structure infections (ABSSSI).