Topic: Food and Drug Administration
SILVER SPRING, Maryland (Reuters) - A new Affymax Inc drug won expert backing to treat anemia in patients with chronic kidney disease who are on dialysis.A Food and Drug Administration advisory panel voted 15-1 on Wednesday, with one abstention, that peginesatide's benefits ...
LOS ANGELES (Reuters) - The Medicare federal health insurance program has confirmed plans to remove a requirement that kidney dialysis providers keep patient hemoglobin levels above a set minimum -- a move likely to reduce use of Epogen, the anemia drug sold ...
AMGN) today announced the publication of results from the first open-label study to compare Nplate (romiplostim) treatment to standard of care therapies (SOC) in non-splenectomized adult patients with chronic immune thrombocytopenia (ITP). Data also showed that patients receiving SOC therapies required splenectomies ...
Argatroban is an anticoagulant that is a small molecule direct thrombin inhibitor . PMID 16148288 In 2000, argatroban was licensed by the Food and Drug Administration (FDA) for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia (HIT).
Summary Box: FDA panel says anemia drugs should remain available for kidney disease patientsVOTE OF CONFIDENCE: A Food and Drug Administration panel of medical experts voted overwhelmingly to allow anemia drugs from Amgen Inc. to remain approved for patients with kidney disease, ...
WASHINGTON (Reuters) - U.S. health officials want advisers' input on the risks of anemia drugs made by Amgen Inc and Johnson & Johnson in certain chronic kidney disease patients, including how to adjust dosing and possible label changes.Food and Drug Administration staff, ...
FDA weighs restrictions of Amgen anemia drugs linked to stroke in kidney disease patientsThe Food and Drug Administration is considering new restrictions on widely used anemia drugs that appear to double the risk of stroke in patients with early-stage kidney disease.The FDA ...
Amgen and FDA notified healthcare professionals that certain lots of Epogen and Procrit (Epoetin alfa) vials are being recalled as a precaution, because the vials may contain extremely thin glass flakes (lamellae) that are barely visible. The potential serious adverse events resulting ...
The U.S. Food and Drug Administration and Amgen have notified health care professionals that certain lots of epoetin alfa (Epogen and Procrit) are being recalled, as product vials may contain extremely thin glass flakes (lamellae) that could result in serious adverse events.. ...
Due to continued reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps, FDA has approved a risk management plan to warn against the use of this drug for such unapproved uses. A data summary of adverse ...
Photo Gallery
-
Star Scientific-Smokeless Tobacco
FILE - In this Sept. 28, 2010 file photo, smokeless tobacco products, including ...AP News - -
FDA Obesity Treatments
In this product photograph provided by Allergan, Inc., the LAP-BAND System is ...AP News - -
Congress Food Safety
FILE - In this Oct. 25, 2010 file photo, Sen. Tom Harkin, D-Iowa ...AP News -
From Around the Web
Video Gallery
-
The FDA's New and Improved ...
The US Food and Drug Administration recently unveiled nine graphic ...2011-08-02 -
FDA Disputes TV Suggestion of Apple ...
The federal Food and Drug Administration and toxicologists are disputing ...2011-09-15 -
FDA to Review Inhalable Caffeine
US Food and Drug Administration officials plan to investigate whether ...2012-02-20
