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 Backs Sapien Heart Valve
Posted on 20. Jul, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — GAITHERSBURG, Md. — An FDA advisory panel has voted 9-0, with one abstention, to recommend approval for Edwards Lifesciences’ Sapien transcatheter heart valve — a novel device intended as an alternative for patients with severe aortic stenosis who are too frail for open-heart surgery.
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Washington Week: ACA Ruling, FDA Panel Move Top News
Posted on 02. Jul, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The first federal appeals court to rule on the healthcare reform law upheld the constitutionality of the individual mandate, and an FDA panel recommended that bevacizumab (Avastin) no longer be used to treat breast cancer.
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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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Washington Week: New Rule to Stop Big Premium Hikes
Posted on 21. May, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The federal government issued a final rule aimed at preventing insurers from drastically raising insurance premiums; an FDA panel recommends new rules to prevent young kids from overdosing on acetaminophen; and the FDA okays a second drug to treat a rare type of pancreatic cancer.
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FDA Panel to Vote on Revoking Approval for Fenofibrate
Posted on 17. May, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The FDA will ask a panel of cardiovascular experts whether it should revoke approval for Abbott’s fenofibric acid (Trilipix) in light of findings from the ACCORD-Lipid trial that called into question the efficacy of using the heart drug as an add-on to statin therapy.
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FDA Panel to Look at Acetaminophen Dosing for Youngest Kids
Posted on 16. May, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The FDA is considering adding dosing instructions on how to give over-the-counter medications that contain acetaminophen to children under 2 — an age group for which there has never been any dosing instructions.
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FDA Panel Narrowly Endorses Bone Graft Device
Posted on 12. May, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — GAITHERSBURG, Md. — An FDA advisory panel narrowly recommended approval for an investigational bone graft device that uses a growth factor protein to regrow bones in the foot and ankle.
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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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