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U.S. FDA Advisory Committee Recommends Approval of Cefiderocol for Treatment of Complicated Urinary Tract Infections

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.

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GSK’s over-the-counter nicotine oral spray gets FDA panel backing

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.

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FDA Advisory Committee Cancels Review of Intra-Cellular’s Schizophrenia Drug

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.

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FDA advisory panel recommends approval of TB Alliance’s tuberculosis treatment

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.

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FDA advisory panel votes against Daiichi Sankyo’s blood cancer treatment

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.

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Advocacy Group and FDA Advisor Call for a Moratorium on Opioid Approvals

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.

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Johnson & Johnson’s nasal spray for depression wins FDA panel backing

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.

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FDA Rejects Alkermes’ Opioid Modulator Treatment for Depression

The U.S. FDA rejected marketing approval of Alkermes’ major depressive disorder treatment ALKS-5461.

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FDA advisory panel split over Sanofi-Lexicon diabetes drug

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.

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Depression treatment fails to get FDA panel backing

An FDA advisory panel voted against approving Alkermes Plc’s depression treatment ALKS 5461 in patients with an inadequate response to standard antidepressant therapies.

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