Regulatory Affairs Syndicator

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.

The breast cancer drug Herceptin (trastuzumab) is now officially available to women with early-stage disease. The US Food and Drug Administration approved the drug for this use earlier this month, though many women had already been receiving the treatment off-label. The drug was previously approved only for women with breast cancer that had spread to other parts of the body (metastatic cancer).

Pfizer Inc.’s pain reliever Celebrex should be approved for treating rheumatoid arthritis in children, a U.S. advisory panel said in a 15-1 vote on Wednesday despite concerns about the drug’s long-term safety.

Pfizer Inc.’s pain reliever Celebrex should be approved for treating rheumatoid arthritis in children, a U.S. advisory panel said in a 15-1 vote on Wednesday despite concerns about the drug’s long-term safety.

Nov. 29 (Bloomberg) — Pfizer Inc. should get U.S. approval to market its Celebrex arthritis-pain pill for use in children because the benefits outweigh the risks, a Food and Drug Administration advisory panel said.

WASHINGTON, Nov. 28 /PRNewswire/ — Should ter

Nov. 29 (Bloomberg) — Pfizer Inc. should get U.S. approval to market its Celebrex arthritis-pain pill for use in children because the benefits outweigh the risks, a Food and Drug Administration advisory panel said.

Food and Drug Administration advisers voted in favor of the Pfizer painkiller Celebrex as an effective treatment of rheumatoid arthritis for children but by a narrow margin agreed that it is not safe.

Shares of medical device maker Possis Medical Inc. surged Wednesday following Food and Drug Administration approval of its AngioJet catheter to remove blood clots in leg veins.

Possis Medical, Inc. announced Wednesday that the Food and Drug Administration approved the marketing of the company’s AngioJet Xpeedior catheter to remove blood clots from blood vessels.

PARIS (AFX) - The US Food and Drug Administration has given Sanofi-Aventis six additional months of patent protection for the old and new versions of its blockbuster Ambien sleep drug, the company said.

PARIS (AFX) - The US Food and Drug Administration has given Sanofi-Aventis six additional months of patent protection for the old and new versions of its blockbuster Ambien sleep drug, the company said.

Possis Medical, Inc. announced Wednesday that the Food and Drug Administration (FDA) approved the marketing of the company’s AngioJet Xpeedior catheter to remove blood clots from blood vessels.

Triarc Cos.’s (TRY) Arby’s Restaurant Group Inc. late Tuesday said it has started serving French fries with no grams of trans fat according to Food and Drug Administration nutrition labeling regulations.

Biotechnology company Progen Industries Ltd. said the Food and Drug Administration gave it clearance to manufacture its anticancer drug candidate PI-88 for a late-stage clinical trial.