Renal Business Today

U.S. Food And Drug Administration (FDA)

Affymax, Takeda Confirm Hematide Strategy

PALO ALTO, Calif.—Affymax and Takeda Pharmaceutical announced Nov. 29 that following pre-New Drug Application (NDA) discussions with the U.S. Food and Drug Administration (FDA), the companies will move forward with their regulatory strategy for the investigational drug, ...More
November 29, 2010
Posted in News, Business, Government & Regulation
AMAG Updates Feraheme Label

LEXINGTON, Mass.—AMAG Pharmaceuticals said Nov. 29 that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding an update to the product label for Feraheme Injection for intravenous (IV) use. ...More
November 29, 2010
Posted in News, Business, Clinical & Pharma, Government & Regulation
NephRx Starts Phase I Trial of Transplant Drug

KALAMAZOO, Mich.—NephRx Corp. announced Nov. 11 that it has started a phase I clinical trial of its transplant drug NX001 and has successfully dosed the first subject in the study. ...More
November 11, 2010
Posted in News, Clinical & Pharma
AMAG Reports Safety Issues with Feraheme, Cuts Workforce

AMAG Pharmaceuticals has reported potential safety issues with its iron management drug Feraheme and has decided to cut 24 percent of its workforce in an effort to restructure the company, the company announced in a news release. ...More
November 1, 2010
Posted in Blog, Clinical & Pharma, Government & Regulation
FDA Warns AMAG Over Drug Websites

The U.S. Food and Drug Administration (FDA) warned AMAG Pharmaceuticals in an Oct. 18 letter about allegedly misleading drug information on its websites. ...More
October 27, 2010
Posted in Blog, Government & Regulation
Rockwell to Start SFP Phase III Trials Within 90 Days

WIXOM, Mich.—Rockwell Medical has released the design of its Phase III development program for Soluble Ferric Pyrophosphate (SFP) and will begin the clinical studies within 90 days, according to a news release. ...More
October 20, 2010
Posted in News, Business, Clinical & Pharma, Government & Regulation
FDA Panel Votes to Continue Use of Anemia Drugs for CKD

A U.S. Food and Drug Administration (FDA) panel voted 15-1 in favor of maintaining approval for erythropoietin-stimulating agents (ESAs) to treat anemia in chronic kidney disease patients, according to a report from NPR. ...More
October 18, 2010
Posted in Blog, Government & Regulation
FDA Grants Orphan Drug Status to Pharmalink Nephropathy Drug

STOCKHOLM—The U.S. Food and Drug Administration has granted orphan drug status to Pharmalink’s Nefecon, which is designed to treat IgA nephropathy. ...More
October 18, 2010
Posted in News, Clinical & Pharma, Government & Regulation
FDA Approves Hema Metrics Anemia Software

SALT LAKE CITY—Hema Metrics announced Oct. 8 that it has received FDA 510 (K) clearance for its anemia management software. ...More
October 8, 2010
Posted in News, Government & Regulation
FDA Warns Fresenius Over Dialysis Products

WASHINGTON—In a Sept. 15 letter, the U.S. Food and Drug Administration (FDA) warned Fresenius Medical Care that it had not properly investigated or fixed problems in two dialysis products and also expressed concern over the company’s phosphate drug Phoslo. ...More
October 6, 2010
Posted in News, Government & Regulation