FDA Panel Endorses Lupus Drug
Posted on 16. Nov, 2010 by Dr. Ellis in News and Updates
ADELPHI, Md. (MedPage Today) — An FDA advisory panel has voted 13 to 2 to recommend approval for belimumab (Benlysta) to treat lupus, despite clinical trials of the drug showing only marginal efficacy. If the FDA approves belimumab, it would be the first new treatment for lupus approved in 50 years.
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FDA Panel Looks at Trials of Devices to Treat Depression
Posted on 08. Oct, 2010 by Dr. Ellis in News and Updates
(MedPage Today) — GAITHERSBURG, Md. — An FDA advisory panel met Friday to discuss how to analyze trials designed to test devices used to treat depression, but didn’t offer the FDA any clear-cut guidance.
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FDA Suggests Afib Drug Okay Even Before Vote
Posted on 17. Sep, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — An FDA advisory panel will vote Monday on whether to recommend approval of the investigational anticoagulant dabigatran to prevent stroke in patients with atrial fibrillation.
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Panel Says No to Reclassifying Cough Syrup Ingredient
Posted on 14. Sep, 2010 by Dr. Ellis in News and Updates
ADELPHI, Md. (MedPage Today) — An FDA advisory panel has voted 15 to 9 against recommending that dextromethorphan — the active ingredient in many common cough medicines — be classified as a controlled substance.
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FDA Panel to Discuss Abuse Potential of Cough Medicine
Posted on 13. Sep, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — An FDA advisory panel is meeting Tuesday to vote on whether to reclassify the active ingredient in more than 125 over-the-counter cough medicines as a controlled substance in order to curb abuse.
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Washington Week: Congress Starts August Recess
Posted on 14. Aug, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The House and Senate have adjourned for their summer recess, but an FDA advisory panel met on an epilepsy drug, and there’s been activity on the healthcare reform front.
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Federal Panel Endorses Ticagrelor for ACS
Posted on 28. Jul, 2010 by Dr. Ellis in News and Updates
ADELPHI, Md. (MedPage Today) — An FDA advisory panel has voted overwhelmingly to recommend approval of AstraZeneca’s investigational antiplatelet drug ticagrelor (Brilinta), saying it appears more effective than clopidogrel (Plavix) for patients with acute coronary syndrome who will be treated either medically or with PCI.
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Keep Rosiglitazone on the Market, FDA Panel Says
Posted on 14. Jul, 2010 by Dr. Ellis in News and Updates
GAITHERSBURG, Md. (MedPage Today) — An advisory panel voted 20-12 to recommend that the FDA allow rosiglitazone (Avandia) to stay on the market, but most panelists want to see the controversial diabetes drug carry tougher warnings on its label.
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FDA Staffers Blast Rosiglitazone at Advisory Panel Meeting
Posted on 13. Jul, 2010 by Dr. Ellis in News and Updates
GAITHERSBURG, Md. (MedPage Today) — The two major FDA critics of rosiglitazone (Avandia) again denounced the diabetes drug during the first day of an advisory committee meeting that will end with a vote on whether the agency should pull it from the market.
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Advisory Panel Faces Tough Call on Rosiglitazone, Experts Say
Posted on 12. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Despite hints that the FDA may be leaning toward pulling rosiglitazone (Avandia) from the market, it’s going to be a tough decision for the advisory committee slated to begin meeting on Tuesday, and things could still go either way, leading endocrinologists predict.
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