FDA Panel Backs Remicade for Kids With Ulcerative Colitis
Posted on 21. Jul, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — An FDA advisory panel has recommended expanding the indication for infliximab (Remicade) to include treatment of ulcerative colitis in children.
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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 Unswayed by Pleas to Retain Breast Ca Indication
Posted on 28. Jun, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — FDA officials held firm in their view that bevacizumab (Avastin) should not be used to treat breast cancer during a heated first day of a two-day hearing, at which breast cancer patients pleaded with the agency to keep the drug available.
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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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Panel Digests Data Linking Food Coloring, Hyperactivity
Posted on 30. Mar, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — Judging from the data and the discussion during the first day of an FDA panel meeting on food dyes, it appears likely that juices, candies, cereals, yogurts, and hundreds of other everyday foods will maintain their brighter-than-bright hues.
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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 Rejects Prostate Drugs for CA Prevention
Posted on 01. Dec, 2010 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — An FDA advisory panel has voted overwhelmingly that GlaxoSmithKline’s dutasteride (Avodart) and Merck’s finasteride (Proscar) should not be used to prevent prostate cancer because the drugs are linked to a higher incidence of high-grade tumors.
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FDA Hears Differing Opinions at Biosimilars Hearing
Posted on 04. Nov, 2010 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — During the second day of the FDA’s public meeting on developing an approval pathway for generic versions of biologics, generic manufacturers took a decidedly different view from companies that make brand name biologics on how the agency should proceed.
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