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WASHINGTON – The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.The consumer group, Public Citizen, filed a petition with the Food and Drug ...Read More

WASHINGTON, Nov 12 (Reuters) - U.S. health regulators,eyeing whether new rules are needed for Internet-deliveredinformation on drugs and medical devices, will hear fromcompanies and consumer groups at a two-day meeting that startsThursday. The Food and Drug Administration is gathering opinions onwhether ...Read More

Utah has agreed to a $24 million settlement with Eli Lilly & Co. over claims the drugmaker engaged in off-label marketing of the anti-psychotic drug Zyprexa, Utah Attorney General Mark Shurtleff said Wednesday. Zyprexa is approved for the treatment of schizophrenia ...Read More

Eager to expand use of the Web to advertise their products, pharmaceutical giants, including Eli Lilly and Pfizer, are heading to Washington this week to call on the Food and Drug Administration to provide guidelines for marketing prescription drugs online. Drug ...Read More

WASHINGTON (Dow Jones)--Hundreds of pharmaceutical experts, advertising specialists and social media gurus will be descending Thursday on Washington to tell the U.S. Food and Drug Administration how it should regulate ads on everything from Google to Facebook. The two-day meeting is ...Read More

The U.S. Food and Drug Administration has granted approval to GlaxoSmithKline’s H1N1 swine flu vaccine, the British pharmaceutical giant announced Tuesday. The U.S. government has ordered 7.6 million doses of the H1N1 vaccine from GlaxoSmithKline, which bases its North American operations ...Read More

Reporting from Washington - Louisiana lawmakers Tuesday threatened the Food and Drug Administration with budget consequences if the agency followed through on a plan to ban Gulf Coast oysters harvested during warm weather that are not treated with antibacterial technology. Industry ...Read More

London-based GlaxoSmithKline won U.S. approval to sell its vaccine to fight H1N1 influenza, also known as swine flu, after an eight-week delay. The Food and Drug Administration cleared the vaccine as a strain change to Glaxo's FluLaval seasonal flu vaccine, the ...Read More

Dr. Margaret A. Hamburg, commissioner of the Food and Drug Administration, sent a letter to all U.S. physicians today thanking them for their help in combating the pandemic H1N1 influenza virus and reassuring them about the safety of the ...Read More

Reporting from New Orleans - Tea parties aren't the only place you'll hear grumbling these days about the imposition of a "nanny state." Just take a seat in any Louisiana oyster bar. On a recent weeknight, Paul Stahls had just polished ...Read More

BusinessWire - Conceptus, Inc. (Nasdaq: CPTS), developer of the Essure(R) procedure, the first proven non-incisional permanent birth control method available, today announced that the United Stated District Court, Northern District of California has denied Conceptus' motion for a preliminary injunction ...Read More

Contact: Michael Herndon of the FDA, +1-301-796-4673, Michael.Herndon@fda.hhs.gov Updated code is a model for state, city, county, tribal, territorial agencies and industry. SILVER SPRING, Md., Nov. 9 /PRNewswire-USNewswire/ -- The Food and Drug Administration today announced the publication of the new FDA ...Read More

The U.S. Food and Drug Administration has extended its review of one of GlaxoSmithKline’s pain treatments. The federal agency has pushed back the review of the New Drug Application for gabapentin encarbil until Feb. 9, 2010. The original date for the ...Read More

Gulf Coast lawmakers have a message for the administration: Keep your mitts off my raw oysters. Senators from Louisiana and Florida are seething over plans to sanitize -- basically cook -- oyster hauls to fight a potentially deadly bacteria found in ...Read More

RICHMOND, Va. (AP) — The Food and Drug Administration said Friday that it had warned several companies to stop selling banned flavored cigarettes to consumers online. The agency sent letters last week to more than a dozen Web-based companies saying they ...Read More

Gloucester Pharmaceuticals, a six-year-old Cambridge biotechnology start-up, has won approval from the Food and Drug Administration to market its first drug in the United States. The drug, called Istodax, treats a rare skin cancer known as cutaneous T-cell lymphoma, or CTCL. ...Read More

The Food and Drug Administration is warning consumers that Stiff Nights, a "dietary supplement" used to promote erections, contains an illegal drug and is potentially dangerous. Following a complaint, the FDA investigated the product and found that it contains sulfoaildenafil, an ...Read More

RICHMOND, Va. (AP) - The Food and Drug Administration said Friday that it has warned several companies to stop selling banned flavored cigarettes to U.S. consumers online. The agency sent letters this week to more than a dozen Web-based companies saying ...Read More

The U.S. Food and Drug Administration is warning consumers that "Stiff Nights," a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal. Following a consumer complaint, the FDA determined ...Read More

WASHINGTON (Reuters) - U.S. regulators warned 10 companies for violating a recently enacted ban on sales of flavored cigarettes, letters released on Friday showed. The Food and Drug Administration told Clove Cigarettes Shop, Durango Smoke Shop Inc and the others to ...Read More

NEW YORK, Nov 5 (Reuters) - Shares of Sunesis Pharmaceuticals rose 45 percent to 55 cents in premarket trading on Thursday, after the company said one of its drugs had received orphan drug designation from the Food and Drug Administration. (ryan.vlastelica@thomsonreuters.com; ...Read More