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  • Listeria: FDA finds problems at Ohio ice cream plant Thursday, 21 May 2015 | 11:32 AM ET

    WASHINGTON— A government investigation of Ohio- based Jeni's Splendid Ice Creams found inadequate testing and cleaning in its Columbus plant that had become contaminated with listeria. The Jeni's recall came as Texas- based Blue Bell Creameries also shut down and recalled all products after listeria in its products was linked to three deaths.

  • Detailed information on the use of medically important antimicrobials- a group of drugs that includes antibiotics, antifungals and antivirals- will help it discern patterns of resistance and identify disease trends, the FDA said in a statement on Tuesday. In an April report on antibiotics that are medically important to humans, the FDA said sales of...

  • WASHINGTON— The Food and Drug Administration is moving to collect more information on antibiotics used in animals that become meat. It's an effort to stem antibiotic-resistant diseases. Data showing what animal species are taking the drugs could help the FDA target its efforts to reduce the amount of antibiotics in meat, the agency said.

  • May 19- The U.S. Food and Drug Administration approved a longer-acting version of Johnson& Johnson's schizophrenia treatment, developed by the company's Janssen Pharmaceuticals unit. The FDA approved the drug, Invega Trinza, to be administered just four times a year, the longest dosing interval available for the treatment of the neurological disorder,...

  • Pernix shares jump on migraine drug approval Friday, 15 May 2015 | 1:03 PM ET

    NEW YORK— Shares of Pernix Therapeutics Holdings Inc. jumped Friday after the Food and Drug Administration expanded approval of the migraine drug Treximet. Treximet has been approved for adults since 2008. Pernix acquired U.S. rights to the drug in 2014 from GlaxoSmithKline. Morristown, New Jersey- based Pernix reported just under $21 million in Treximet...

  • May 15- The U.S. Food and Drug Administration on Friday warned that a widely used newer class of type 2 diabetes drugs sold by AstraZeneca, Johnson& Johnson and Eli Lilly in partnership with Boehringer Ingleheim may cause dangerously high levels of blood acids that could require hospitalization. The FDA said its Adverse Event Reporting System database...

  • U.S. FDA warns on newer class of type 2 diabetes drugs Friday, 15 May 2015 | 11:06 AM ET

    May 15- The U.S. Food and Drug Administration on Friday warned that a widely used newer class of type 2 diabetes drug sold by AstraZeneca, Johnson& Johnson and Eli Lilly in partnership with Boehringer Ingleheim may a cause dangerously high levels of blood acids that could require hospitalization. They include AstraZeneca's Farxiga, J&J's Invokana and...

  • Ranbaxy filed "grossly inadequate" applications seeking approval for its drugs and deceived the FDA into granting approvals and giving the company market exclusivity, the class action lawsuit asserts. The FDA has banned import of drugs from all of Ranbaxy's India- based plants under a wider scrutiny of the country's $15 billion pharmaceutical industry,...

  • WASHINGTON— The Food and Drug Administration is outlining its plan to end the nation's lifetime ban on blood donations from gay and bisexual men, a 32- year-old policy that many medical groups and gay activists say is no longer justified. The FDA on Tuesday released proposed guidelines for screening blood donors at increased risk of carrying HIV.

  • Vertex Pharmaceuticals has asked the Food and Drug Administration to approve its twice-a-day drug for patients with the most common form of cystic fibrosis, a deadly inherited disease that causes sticky mucus buildup in the lungs and other organs, leading to infections and early death. A panel of FDA expert advisers voted 12-1 in favor of approval for the drug,...

  • After publishing draft guidance, the FDA invites comments and holds public hearings. The FDA may then also seek expert recommendations before making a final decision. Some experts indicated support for a change in the rule on blood donations by MSMs in an FDA panel discussion in December, but did not make any recommendations.

  • *FDA slated to make decision on treatment on July 5. FDA questioned whether Vertex Pharmaceuticals Inc's experimental combination therapy for cystic fibrosis had an added benefit over the company's already approved therapy, Kalydeco, in patients with the most common genetic mutation behind the deadly disease. The FDA is slated to make a decision on Orkambi...

  • May 8- Vertex Pharmaceuticals Inc's combination of an experimental compound and an approved drug significantyly improved lung function in cystic fibrosis patients with the most common genetic mutation underlying the disease, FDA staff said. The FDA is trying to ask the panel if the evidence is enough to show that the combination's benefit is significantly...

  • May 8- FDA staff reviewers questioned whether Vertex Pharmaceuticals Inc's experimental cystic fibrosis drug added any benefit over its already approved therapy, Kalydeco, in patients with the most common genetic mutation underlying the disease. Vertex is seeking approval for the combination of the compound lumacafotor and Kalydeco to treat CF patients...

  • AUSTIN, Texas, May 7- Texas- based Blue Bell Creameries had a Listeria problem at its Oklahoma plant as early as 2013 and did not do enough to make sure its factory was sanitized, according to documents from the U.S. Food and Drug Administration. Health officials had said three people made ill by Listeria between January 2014 and January 2015 had died in a Kansas...

  • AUSTIN, Texas, May 7- Texas- based Blue Bell Creameries likely knew as early as 2013 of a Listeria problem at its Oklahoma plant and did not do enough to make sure its factory was sanitized, according to documents from the U.S. Food and Drug Administration. The FDA also found problems at Blue Bell plants in Sylacauga, Alabama, and Brenham, Texas. The FDA posted the...

  • May 7- Amarin Corp Plc filed suit against the U.S. Food and Drug Administration on Thursday for restricting its right to promote its fish oil drug Vascepa for an unapproved, or off-label, use. The suit, filed on Thursday in U.S. District Court for the Southern District of New York, argues that the FDA's ban violates Amarin's right to free speech under the First...

  • WASHINGTON, May 6- The U.S. Food and Drug Administration will hold a public meeting this summer to address drug company concern that restrictions on what they can say about off-label use of drugs violate their first amendment right to free speech. Efforts by drug companies to change the rules gained steam after a 2012 decision from the Second Circuit Court of...

  • May 4- AcelRx Pharmaceuticals Inc said a division of the U.S. Food and Drug Administration had rejected the company's request for a meeting to discuss the need for an additional trial of its pain drug device, Zalviso. The company's shares fell about 32 percent to $2.85 in after-market trading on Monday after the FDA also restated its view that the additional...

  • April 30- The U.S. Food and Drug Administration on Thursday approved The Medicines Co's dry powder blood-clotting agent for use in hospital settings, a month after the treatment received approval in Europe. The approval comes at a time Medicines Co is facing a drop in sales of its lead product, Angiomax anticoagulant injection, which accounted for over 80...