Regulatory Affairs Syndicator

NEW YORK, November 30 (newratings.com) – A US FDA (Food and Drug Administration) advisory panel Wednesday recommended that the use of Pfizer Inc’s ( PFE.NYS ) pain reliever Celebrex should be broadened to treat children with juvenile rheumatoid arthritis.

LONDON (AFX) - Diagnostics company Axis-Shield PLC said it has received marketing approval from the US Food and Drug Administration for a test to measure vitamin B12 deficiency, which leads to conditions such as Alzheimer’s disease.

Children as young as 2 who suffer from arthritis can be treated with Celebrex , but to ensure the painkiller doesn’t put them at later risk for heart attacks, their health should be tracked for decades, a Food and Drug Administration advisory panel said yesterday.

They want Pentagon to determine if Factor VII’s risks outweigh benefits Two U.S. senators called on the Pentagon yesterday to investigate the military’s use of a largely experimental blood-coagulating drug that doctors inject into wounded troops to control bleeding but that has been linked to unexpected and potentially deadly blood clots.

They want Pentagon to determine if Factor VII’s risks outweigh benefits Two U.S. senators called on the Pentagon yesterday to investigate the military’s use of a largely experimental blood-coagulating drug that doctors inject into wounded troops to control bleeding but that has been linked to unexpected and potentially deadly blood clots.

Should terminally ill patients be allowed access to drugs not approved by the Food and Drug Administration? That is the question a panel of experts will discuss and debate at a landmark Colloquium, Whose Life Is It, Anyway?, sponsored by the Food and Drug Law Institute (FDLI), Feb. 27, 2007, in Washington, D.C. [click link for full article]

Biopure Corporation (Nasdaq: BPUR) announced today that the Food and Drug Administration’s (FDA) Blood Products Advisory Committee will meet in open session on December 14, 2006 to discuss the Navy’s proposed RESUS clinical trial of Biopure’s investigational oxygen therapeutic Hemopure(R) [he [click link for full article]

By STEVE MITCHELL Novartis said toxicity concerns may delay the Food and Drug Administration’s action on Galvus for diabetes and Tekturna for hypertension, but analysts still see a positive future for the company.

By Gzedit FINALLY, the U.S. Food and Drug Administration is warning doctors and patients of the deadly potential of methadone, and has revised dosage information included with the drug. This action, although late, may save lives.

Seemingly undaunted by his failure to push through legislation in 2005 that sought to protect ” pharmacists of conscience ” (that is, pro-life pill counters) from having to fill scrips for emergency contraceptives – or by the larger defeat inherent in the U.S. Food and Drug Administration ’s decision to approve over-the-counter sales status for the EC Plan B – Rep.

Key points : Receives green light from the Food and Drug Administration (FDA) to manufacture PI-88 for upcoming Phase III trial Manufacturing in-house saves Progen approximately AUD$7.8 m in outsourcing fees Successful FDA meeting forms basis for New Drug Application (NDA) Chemistry Manufacturing and Control (CMC) section submission (Full text of a statement.

WASHINGTON, Nov. 29 (UPI) — Novartis said toxicity concerns may delay the Food and Drug Administration’s action on Galvus for diabetes and Tekturna for hypertension, but analysts still see a positive future for the company.

WEDNESDAY, Nov. 29 (HealthDay News) — A U.S. Food and Drug Administration advisory panel recommended Wednesday that use of the painkiller Celebrex be expanded to treat children with juvenile rheumatoid arthritis.

Shares of Possis Medical Inc. of Coon Rapids jumped nearly 10 percent Wednesday after the U.S. Food and Drug Administration approved the use of its AngioJet Xpeedior catheter to remove blood clots from legs. Possis shares closed at $12.51, up $1.10, after hitting $13.25 earlier in the day. More than 500,000 shares changed hands, about 12 times the average daily volume. The share price broke

CONCORD, N.H. New Hampshire will become the first state to offer a new cervical-cancer vaccine free to all girls. The Food and Drug Administration approved the vaccine in…