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  • Aug 3- The U.S. Food and Drug Administration has, for the first time, approved a drug that uses 3 D printing technology, paving the way for potential customization of drugs to suit patients' needs. The drug, made by privately held Aprecia Pharmaceuticals Co, was approved for oral use as a prescription adjunctive therapy in the treatment of epilepsy, the company said on...

  • Hospira headquarters

    The federal government says health care facilities should stop using Hospira's Symbiq medication infusion pump because its vulnerable to hacking.

  • BOSTON, July 31- The U.S. Food and Drug Administration on Friday advised hospitals not to use Hospira Inc's Symbiq infusion system, saying a security vulnerability could allow cyber attackers to take remote control of the system. Both the FDA and DHS said they know of no cases where such an attack has been launched, but the FDA said in its advisory that it strongly...

  • July 31- The U.S. Food and Drug Administration said it is investigating the latest outbreak of cyclosporiasis in the United States. The Centers for Disease Control and Prevention has been notified of about 358 confirmed cases of the infection until Thursday, the FDA said in a statement on its website. Wal-Mart Stores Inc and Kroger Co are pulling some cilantro...

  • New treatment for obesity Wednesday, 29 Jul 2015 | 6:00 AM ET
    New treatment for obesity

    The FDA approves a non-surgical device for treating obesity.

  • Praluent priced on value: Regeneron CEO Monday, 27 Jul 2015 | 8:45 AM ET
    Praluent priced on value: Regeneron CEO

    Leonard Schleifer, Regeneron president & CEO, discusses the FDA's approval of its cholesterol-lowering drug Praluent, and concerns over pricing the new drug. With Jeffrey Sonnenfeld, Yale School of Management.

  • 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...

  • 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...

  • 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...

  • 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.

  • 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.

  • 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,...

  • July 13- The U.S. Food and Drug Administration approved AstraZeneca Plc's drug, Iressa, as a first-line treatment for a common form of lung cancer. The FDA said on Tuesday the approval was based on results from a trial of 106 patients with previously untreated non-small cell lung cancer. The National Cancer Institute estimates more than 158,000 will die from the...

  • July 13- The U.S. Food and Drug Administration has approved AstraZeneca Plc's drug, Iressa, as a first-line treatment for a common form of lung cancer. The drug was previously approved for use in non-small cell lung cancer patients only after they did not respond to chemotherapy. The FDA said on Tuesday the approval was based on results from a trial of 106 patients...