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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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U.S. FDA panel backs Celltrion biosimilar

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.

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FDA staff says AcelRx opioid painkiller is not better than rivals

AcelRx Pharmaceuticals Inc.’s opioid painkiller offers no apparent advantage to currently available therapies, staff reviewers of the U.S. Food and Administration said.

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FDA Advisory Panel Supports Paratek’s Investigational Antibiotic, PDUFA Set for October

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).

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