FDA Considering Tighter Standards for Bioequivalency
Posted on 26. Jul, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — An FDA advisory committee met Tuesday to discuss the agency’s proposed standards for determining when generic drugs can be considered bioequivalent to the brand-name version of the medication.
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FDA Panel Votes to Yank Avastin’s Breast Cancer Indication
Posted on 29. Jun, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — An FDA advisory committee has voted unanimously, 6-0, that Genentech’s bevacizumab (Avastin) should no longer be approved to treat metastatic HER2-negative breast cancer.
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FDA Panel Endorses Novel HAE Drug
Posted on 24. Jun, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — An FDA advisory committee has voted 12-1 to recommend approval for icatibant (Firazyr) to treat hereditary angioedema (HAE) attacks.
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FDA Panel Has No New Echo Contrast Agent Conclusions
Posted on 03. May, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — An FDA advisory committee met Monday to decide whether the black box warning on microbubble contrast agents used in echocardiography is too strict, but came to little agreement over whether the box should be removed.
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FDA Panel Endorses Another Hep C Drug
Posted on 28. Apr, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — Hepatitis C patients will likely have two new treatment options after an FDA advisory committee unanimously endorsed a second new HCV drug in as many days.
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BREAKING NEWS:FDA Panel Endorses New Antibiotic for C. Diff
Posted on 05. Apr, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — An FDA advisory committee has voted unanimously to recommend approval of the investigational narrow-spectrum antibiotic fidaxomicin (Dificid) to treat Clostridium difficile-associated diarrhea.
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FDA Panel Rejects Cystic Fibrosis Drug
Posted on 12. Jan, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — An FDA advisory committee has voted against approval of liprotamase (Sollpura), a pancreatic enzyme product for cystic fibrosis and other diseases that cause pancreatic insufficiency, saying there is not enough evidence that the drug works better than agents already on the market.
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Panel Endorses Weight-Loss Drug
Posted on 07. Dec, 2010 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — An FDA advisory committee has voted 13-7 that the modest weight-loss benefits of an investigational combination of naltrexone and bupropion (Contrave) outweigh the drug’s blood pressure risk.
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FDA Panel Turns Thumbs Down on Weight-Loss Drug
Posted on 16. Sep, 2010 by Dr. Ellis in News and Updates
ADELPHI, Md. (MedPage Today) — An FDA advisory committee has voted 9-5 not to recommend lorcaserin hydrochloride (Lorqess), a new weight-loss drug.
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Equivocal Message on Duloxetine for Pain from Panel
Posted on 19. Aug, 2010 by Dr. Ellis in News and Updates
(MedPage Today) — BETHESDA, Md. — An FDA advisory committee has voted narrowly — 8 to 6 — to recommend that the agency expand the indication for the antidepressant duloxetine (Cymbalta) to treat chronic musculoskeletal pain.
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