Renal Business Today

U.S. Food And Drug Administration (FDA)

FDA Updates Vytorin Label After CKD Study

WHITEHOUSE STATION, N.J.—The U.S. Food and Drug Administration (FDA) has approved an updated label for Merck's cholesterol drug Vytorin following results from the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease. ...More
3 weeks ago
Posted in News, Clinical & Pharma
FDA Fast Tracks Allocure’s Investigational AKI Treatment

BURLINGTON, Mass.—The U.S. Food and Drug Administration (FDA) has granted fast-track designation to Allocure Inc.’s AC607, which is an investigational treatment for acute kidney injury (AKI). ...More
January 6, 2012
Posted in News
FDA Panel Votes in Favor of Affymax Anemia Drug

A federal panel has voted 15-1 in favor of recommending the FDA approval of Affymax's anemia drug peginesatide, according to a Dec. 7 report from the San Francisco Business Times. ...More
December 7, 2011
Posted in Blog, Clinical & Pharma, Government & Regulation
FDA Recommends Vytorin Approval in CKD Patients

WHITEHOUSE STATION, N.J.— Merck announced Nov. 2 that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of Merck's Vytorin for use in patients with pre-dialysis chronic kidney ...More
November 2, 2011
Posted in News
FDA to Review Peginesatide in December

PALO ALTO, Calif. –The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for Affymax’s peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult ...More
October 24, 2011
Posted in News, Government & Regulation
FDA Approves B. Braun Closed IV Catheter

BETHLEHEM, Pa.—The U.S. Food and Drug Administration (FDA) has approved B. Braun Medical’s Introcan Safety 3 Closed IV Catheter. ...More
October 20, 2011
Posted in News, Business, Government & Regulation
Sensipar Label Gets Safety Update

The U.S. Food and Drug Administration has approved a change to the safety labeling of Amgen’s Sensipar (cinacalcet). ...More
September 13, 2011
Posted in Blog, Clinical & Pharma, Government & Regulation
Bone Drug Increases Kidney Failure Risk

WASHINGTON—The U.S. Food and Drug Administration (FDA) is warning that Novartis‘ osteoporosis drug Reclast (zoledronic acid) increases the risk of kidney failure. ...More
September 2, 2011
Posted in News, Clinical & Pharma
FDA Approves Abbott Renal Stent System

ABBOTT PARK, Ill.—The U.S. Food and Drug Administration (FDA) has approved Abbott’s RX Herculink Elite Renal Stent System for the treatment of renal artery stenosis in patients with uncontrolled hypertension. ...More
August 11, 2011
Posted in News, Clinical & Pharma, Government & Regulation
FDA Accepts New Drug Application for Peginesatide

PALO ALTO, Calif.—The U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for Affymax and Takeda’s anemia drug peginesatide, which is being developed to treat anemia in dialysis patients. ...More
July 27, 2011
Posted in News, Clinical & Pharma, Government & Regulation

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