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  • The FDA typically follows the advice of its advisory panels. The FDA review found a statistically significant improvement in the number of satisfying sexual events experienced by women taking the drug and a reduction in distress related to low desire. The differences were numerically small, however, and the question remains whether the drug's benefits...

  • Altria Group Inc, Reynolds American Inc and Lorillard Inc dismissed their case after the FDA on May 29 said it would review whether to mandate advance approval for label alterations such as changes to logos and background colors, or the use of descriptors such as "premium tobacco." In their April lawsuit filed in federal court in Washington, D.C., the companies said...

  • Tobacco companies drop lawsuit vs FDA over labeling Tuesday, 2 Jun 2015 | 1:27 PM ET

    In a filing with the federal court in Washington, D.C., units of Altria Group Inc, Reynolds American Inc and Lorillard Inc said they decided to dismiss their case after the FDA on May 29 said it would review a policy governing the labeling of tobacco products.

  • FDA panel to discuss Lilly's lung cancer drug approval Tuesday, 2 Jun 2015 | 11:10 AM ET

    June 2- The U.S. Food and Drug Administration said a panel of experts would discuss a marketing application from Eli Lilly& Co on a new targeted lung cancer treatment. The FDA said the panel would review data that showed improved overall survival rate in lung cancer patients treated with a combination of Lilly's experimental drug, necitumumab, and chemotherapy...

  • The review, published on the FDA's website on Tuesday, comes two days before a meeting of external advisers who will discuss the drug and recommend whether it should be approved. The FDA typically follows the advice of its advisory panels. The difference was numerically small, however, and the question remains whether the drug's benefits outweigh the risks, the...

  • June 2- A drug to increase sexual desire in women showed a statistically significant benefit, according to a preliminary review by the U.S. Food and Drug Administration, but the agency raised concerns about an increased risk of fainting and falling blood pressure. "The fundamental question is whether these observed placebo-corrected treatment effects...

  • 'Viagra for women' gets push for FDA approval Monday, 1 Jun 2015 | 12:02 PM ET
    A tablet of flibanserin at Sprout Pharmaceuticals in Raleigh, N.C.

    A campaign accuses the FDA of gender bias for approving drugs to help men have sex, but none for women. The NYT reports.

  • WASHINGTON, May 28- The U.S. Food and Drug Administration on Thursday approved the first drug to treat a rare, progressive lung disease that mainly affects women of childbearing age. The drug, Rapamune, known chemically as sirolimus, is made by Pfizer Inc and is designed to treat lymphangioleiomyomatosis, a disease that causes lung damage and affects only two to...

  • U.S. court grants exclusivity for Amarin's Vascepa Thursday, 28 May 2015 | 2:26 PM ET

    May 28- A U.S. district court has ruled that Amarin Corp's fish oil pill, Vascepa, is eligible for five years of marketing exclusivity, setting aside a U.S. Food and Drug administration decision. Amarin's shares rose as much as 44 percent to $2.80 on the Nasdaq. The case is Amarin v.

  • Assuming approval from the U.S. Food and Drug Administration, Amgen Inc. will offer its drug, Repatha, as a biweekly 140 mg injection or a monthly injection of 420 mg, while Praluent, from Regeneron Pharmaceuticals Inc and Sanofi, will be offered in biweekly injections of 75 mg or 150 mg. Regeneron and Sanofi could enjoy a significant pricing advantage with their...

  • 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...

  • 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,...

  • 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,...

  • 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...