The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted against recommending Merck’s checkpoint inhibitor Keytruda (pembrolizumab) as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery.
Nektar Therapeutics withdrew the application for the company’s opioid painkiller for adults with chronic low back pain, after a U.S. Food and Drug Administration panel unanimously voted against the drug’s approval.
Independent experts on an FDA advisory panel voted against the use of an already approved drug from Eli Lilly and Boehringer Ingelheim as an add-on to insulin therapy for type 1 diabetes.
An FDA advisory panel voted against approving Alkermes Plc’s depression treatment ALKS 5461 in patients with an inadequate response to standard antidepressant therapies.
The U.S. FDA’s PCNSC voted against a recommendation for Sarepta Therapeutics’ eteplirsen for Duchenne Muscular Dystrophy (DMD).
An independent panel of experts advising the U.S. Food and Drug Administration recommended that Clovis Oncology Inc’s lung cancer drug not be approved based on existing trial data. The panel voted 12-1 against giving the drug an accelerated approval, and recommended the FDA wait for the results from an ongoing late-stage trial that compares the […]