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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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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Brain Tumor Blaster Endorsed by FDA Panel
Posted on 17. Mar, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — GAITHERSBURG, Md. — An FDA advisory panel says the benefits of a novel device that blasts glioblastoma multiforme brain tumors with an electrical field outweigh any risks.
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Panel Recommends Cautious Use of Anesthesia in Kids
Posted on 10. Mar, 2011 by Dr. Ellis in News and Updates
WASHINGTON –The possible link between anesthesia exposure and brain development in young children is still too poorly understood to sound the alarm bells, an FDA advisory panel decided.
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FDA Panel to Vote on Approval, Dosing for COPD Drug
Posted on 07. Mar, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — An FDA advisory panel will vote Tuesday on whether a novel long-acting beta-adrenergic agonist is safe and effective at treating airflow obstruction in patients with chronic obstructive pulmonary disease.
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Washington Week: Finally, A Longer-Term SGR Fix
Posted on 11. Dec, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Congress passed a year-long doctor payment fix this week, and an FDA advisory panel endorsed what could become the first new pharmaceutical option in weight loss in a decade.
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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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Panel Splits over Skin Cancer Detection Device
Posted on 18. Nov, 2010 by Dr. Ellis in News and Updates
(MedPage Today) — COLLEGE PARK, Md. — An FDA advisory panel has voted 8-7, with one member abstaining, to recommend approval for an experimental skin cancer detection system called MelaFind.
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FDA Panel Endorses Gardasil for Anal Cancer
Posted on 17. Nov, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — An FDA advisory panel has expressed its support for expanding the indication on the quadrivalent human papillomavirus recombinant vaccine Gardasil to prevent anal intraepithelial neoplasms and anal cancer in males and females ages 9 through 26.
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