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  • FDA approves stomach-filling balloon for weight loss Tuesday, 28 Jul 2015 | 5:24 PM ET

    Patients are sedated during the procedure, which takes less than 30 minutes, according to an FDA release. The FDA previously approved another balloon device for weight loss but it was withdrawn in 1992 due to a safety issue in which the balloon could rupture and block patients' arteries. "The new device aims to address the design failings of the earlier device," said...

  • TRENTON, N.J.— An experimental drug for one of the hardest-to-treat types of hepatitis C has been approved by the Food and Drug Administration, adding to the surge of new options— all much more effective but extremely costly— for patients with the liver-destroying virus. Daklinza, developed by New York- based Bristol-Myers Squibb Co., is the first drug approved to...

  • July 24- The U.S. Food and Drug Administration on Friday approved two treatments for less common forms of hepatitis C virus infections. The regulator cleared AbbVie Inc's Technivie, which targets HCV genotype 4 infections, and Bristol-Myers Squibb Co's Daklinza, used to treat HCV genotype 3 infections. Technivie, includes the same cocktail of drugs that...

  • EAST RUTHERFORD, N.J.— A new drug for advanced basal cell carcinoma, an increasingly common cancer in the skin's top layer, has won Food and Drug Administration approval. The drug, known chemically as sonidegib, is a daily pill developed by Swiss drugmaker Novartis AG, which has U.S. pharmaceuticals headquarters in East Hanover, New Jersey. Novartis hasn't...

  • WASHINGTON, July 24- The U.S. Food and Drug Administration approved a potent new cholesterol-lowering drug from Sanofi SA and Regeneron Pharmaceuticals Inc on Friday but limited its approved use to patients with a hereditary form of the condition and those with cardiovascular disease. The FDA ruling came just hours after European regulators recommended...

  • WASHINGTON— The Food and Drug Administration on Friday approved a first-of-a-kind drug that lowers artery-clogging cholesterol more than older drugs that have been prescribed for decades. The drug from Sanofi and Regeneron Pharmaceuticals Inc. offers an important new option for millions of patients at high risk of heart disease. But the drug's sky-high...

  • July 24- The U.S. Food and Drug Administration approved Novartis AG's oral pill to treat the most common form of advanced skin cancer. Roche Holding AG's Erivedge was the first pill to be approved in 2012 by the FDA for the condition. One in five Americans are likely to develop skin cancer in their lifetime, according to the American Academy of Dermatology.

  • July 24- The U.S. Food and Drug Administration approved AbbVie Inc's treatment that targets hepatitis C virus with the rarest genotype, or genetic makeup. The three drugs included in Technivie are also in Viekira Pak, AbbVie's treatment for genotype 1 hep C virus infection. Separately, AbbVie reported lower-than-expected revenue for the first time in six...

  • Proposed label would give context to sugar in foods Friday, 24 Jul 2015 | 12:20 PM ET

    The Food and Drug Administration on Friday proposed that nutrition facts labels include the percentage of your recommended daily intake of added sugars in a food item— the "percent daily value." The FDA proposal would be based on that number, meaning that added sugars should be no more than 200 calories, or about 50 grams, in a recommended daily diet of 2,000...

  • FDA approves Novartis's advanced skin cancer drug Friday, 24 Jul 2015 | 12:19 PM ET

    July 24- The U.S. Food and Drug Administration approved Novartis AG's oral pill to treat the most common form of advanced skin cancer.

  • Abbvie gets U.S. FDA approval for Hep C drug Friday, 24 Jul 2015 | 11:42 AM ET

    July 24- The U.S. Food and Drug Administration approved Abbvie Inc's treatment that targets the most common genotype, or genetic makeup, of hepatitis C virus. The drug, Technivie, was approved for the treatment of hepatitis C virus genotype 4 infections, the regulator said on Friday. The drug is approved for use in combination with the compound, ribavirin, for the...

  • July 24- Food companies would be required to label the amount of added sugar as a percentage of recommended daily calorie intake under a proposal on Friday by the U.S. Food and Drug Administration. Susan Mayne, director of the Center for Food Safety and Applied Nutrition at the FDA, said on a conference call with reporters that the agency hoped to partner with other...

  • July 24- Companies would be required to label the amount of added sugar as a percent of recommended daily calorie intake under a proposal on Friday by the U.S. Food and Drug Administration. Last year, the agency proposed updating the Nutrition Facts label to include added sugars but it did not require companies to declare the amount of sugar as a percentage.

  • NEW YORK— Shares of Sunesis Pharmaceuticals plunged in aftermarket trading Thursday after the company said it will focus on trying to get its blood cancer drug Qinprezo on the market in Europe because regulators in the U.S. won't approve it based on available data. The Food and Drug Administration doesn't support a filing, Sunesis said. Sunesis shares fell...

  • July 23- Sunesis Pharmaceuticals Inc said the U.S. Food and Drug Administration called for more clinical evidence before considering approval for its cancer drug, sending the company's shares down 60 percent in after-market trading. Sunesis said it would work to complete its filing as fast as possible in Europe and refine its plan to gain approval in the...

  • July 23- Sunesis Pharmaceuticals Inc said the U.S. Food and Drug Administration did not support the filing of a regulatory application for its experimental cancer drug, sending the company's shares down 60 percent in after-market trading. The FDA asked the company for more clinical evidence to support its marketing application, Sunesis said.

  • Bristol-Myers says HIV drug gets FDA incentives Tuesday, 21 Jul 2015 | 1:13 PM ET

    The Food and Drug Administration designated the drug BMS-663068 as a breakthrough treatment, so Bristol-Myers Squibb Co. will get extra meetings with the FDA and earlier communication with scientists as it studies the drug. There are six classes of HIV drugs, according to the National Institutes of Health, and patients are typically treated with drugs from...

  • Europe approves Amgen's first-in-class cholesterol drug Tuesday, 21 Jul 2015 | 10:49 AM ET

    WASHINGTON— Amgen on Tuesday received European approval for its first-of-a-kind cholesterol drug that lowers levels of the artery-clogging substance more than older drugs that have been prescribed for decades. The U.S. Food and Drug Administration is scheduled to make a decision on a similar drug from Sanofi and Regeneron Pharmaceuticals this Friday.

  • Novo Nordisk says Flexpro PenMate gets FDA approval Thursday, 16 Jul 2015 | 12:18 PM ET

    COPENHAGEN, July 16- The PenMate injection device for use with Novo Nordisk's Norditropin Flexpro treatment for growth hormone-related disorders has been approved by the U.S. Food and Drug Administration, Novo Nordisk said on Thursday. The device is designed to hide the needle injecting Norditropin into patients. Norditropin is used for children and...

  • Zogenix delays epilepsy drug trials by three months Tuesday, 14 Jul 2015 | 9:50 AM ET

    July 14- Drug developer Zogenix Inc said it would delay by three months the start of late-stage trials for its drug to treat a rare form of epilepsy in children. Zogenix decided to delay the trials for ZX008 after the U.S. Food and Drug Administration asked for more patients to be enrolled in the studies. Zogenix plans to enroll 105 patients in each of the two trials,...