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  • FDA warns St Jude heart device parts may be faulty Friday, 22 Jan 2016 | 6:33 PM ET
    Illustration of St. Jude Medical's LibraXP device

    St Jude Medical Inc said the FDA has issued a Class I recall on faulty parts of its devices implanted into patients to control irregular heartbeats.

  • FDA gives full approval to Amgen blood cancer drug Thursday, 21 Jan 2016 | 5:23 PM ET

    Jan 21- The U.S. Food and Drug Administration said on Thursday it has approved Amgen Inc's cancer drug Kyprolis in combination with certain other therapies to treat patients with multiple myeloma. The agency also approved the drug as a single agent for patients with relapsed or refractory multiple myeloma who have received one or more previous treatments.

  • FDA postpones panel meeting to review Sarepta's DMD drug Wednesday, 20 Jan 2016 | 5:59 PM ET

    Jan 20- The U.S. Food and Drug Administration postponed a meeting of its advisory panel to review Sarepta Therapeutics Inc's drug for a rare muscle wasting disorder due to inclement weather forecast for Washington DC. The date of the meeting, which was scheduled for Friday, will be announced later, the FDA said. There are no FDA- approved drugs for DMD, and pressure...

  • Jan 20- Zafgen Inc reported positive data on its obesity drug, which has been marred by two patient deaths, and said the data could help convince the U.S. Food and Drug Administration to allow it to restart trials on the drug. Leerink analysts found the data encouraging and said that despite the two deaths, an effective patient screening process and a risk...

  • Jan 20- Zafgen Inc said data showed its experimental obesity drug was successful in treating patients with a rare genetic eating disorder, before the late-stage study was placed on hold after two patients died. The U.S. Food and Drug Administration ordered in December that all tests on the drug be completely halted after a second patient died from an artery...

  • Zafgen says obesity drug succeeds in late-stage study Wednesday, 20 Jan 2016 | 6:21 AM ET

    Jan 20- Zafgen Inc said its experimental obesity drug, on complete clinical hold since last month after the death of two patients, met its main goals in a late-stage study in patients with a rare genetic eating disorder. The U.S. Food and Drug Administration ordered in December that all trials on the drug be stopped after the death of a second patient.

  • Supporters at Taiwan's main opposition Democratic Progressive Party (DPP) hold up piggy banks at a party fundraiser in Taipei.

    Besides the territory's relationship with China, there other topics Taiwan voters are focused on: trade, identity and, err, pork.

  • Jan 15- The U.S. Food and Drug Administration on Friday issued draft guidelines to medical device makers on how to protect patients from cybersecurity vulnerabilities in their devices. Joshua Corman, founder of I Am The Cavalry, a cybersafety advocacy group who worked with the FDA on the guidance, said he was extremely encouraged by the agency's action.

  • Jan 15- The U.S. Food and Drug Administration on Friday issued draft guidelines to medical device makers on how to protect patients from cybersecurity vulnerabilities in the devices. "Cybersecurity threats to medical devices are a growing concern," the agency said in a statement. "The exploitation of cybersecurity vulnerabilities presents a potential risk to...

  • Jan 15- The U.S. Food and Drug Administration on Friday cleared Japan's Olympus Corp's duodenoscope with changes to the device's design and labeling, intended to help reduce the risk of bacterial infections. Physicians perform about 500,000 such procedures every year in the United States. Other companies that sell duodenoscopes in the United States include...

  • Jan 15- The U.S. Food and Drug Administration on Friday cleared Japan's Olympus Corp's duodenoscope with changes to the device's design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model being used in health care facilities to fix them as quickly as possible, the regulator said.

  • The FDA report comes a day after the U.S. regulator rejected BioMarin Pharmaceutical Inc's rival drug Kyndrisa. There are no FDA- approved drugs for DMD, and pressure has been mounting on the U.S. regulator to quickly approve treatments. The FDA staff questioned the validity of the' small' study used by Sarepta to test its drug's efficacy, saying they considered the...

  • Jan 15- U.S. Food and Drug Administration staff said on Friday Sarepta Therapeutics Inc did not provide enough evidence to support the effectiveness of its drug to treat a rare muscle wasting disorder. Both drugs target a particular subset of DMD patients, which translates into an addressable population of about 1,800 boys in the United States and about 5,000...

  • Jan 15- U.S. Food and Drug Administration staff said on Friday Sarepta Therapeutics Inc did not provide enough evidence to support the effectiveness of its drug to treat a rare muscle wasting disorder. The drug, eteplirsen, is designed to treat a particular subset of Duchenne muscular dystrophy patients. Sarepta's shares plunged 40 percent in premarket...

  • MUMBAI, Jan 15- Indian drugmaker Wockhardt Ltd said the U.S. Food and Drug Administration had issued a notice outlining manufacturing violations at its Shendra plant in western India, delaying the company's plans to rebuild its battered U.S. business. In a so-called' Form 483' issued to the company after a recent inspection of the plant, the FDA listed nine...

  • UPDATE 1-FDA delays decision on Heron's nausea drug Friday, 15 Jan 2016 | 7:23 AM ET

    Jan 15- Heron Therapeutics Inc said the U.S. Food and Drug Administration had postponed a decision on its injectable drug to treat chemotherapy-induced nausea. The FDA is now expected to decide on Sustol by late February instead of the earlier deadline of Sunday, Heron said on Friday. Chemotherapy-induced nausea and vomiting, considered one of the most acute...

  • FDA delays decision on Heron's nausea drug Friday, 15 Jan 2016 | 6:59 AM ET

    Jan 15- Heron Therapeutics Inc said the U.S. Food and Drug Administration will delay a decision on its injectable drug to treat chemotherapy-induced nausea.

  • *Kyndrisa had received negative FDA review in Nov. The rejection caps months of uncertainty surrounding the drug, Kyndrisa, which was billed to be the first treatment in the United States for Duchenne muscular dystrophy. A panel of independent advisers to the FDA had in November indicated that Kyndrisa's effectiveness in trials was not enough to warrant...

  • UPDATE 1-FDA rejects BioMarin's DMD drug Thursday, 14 Jan 2016 | 8:51 AM ET

    Jan 14- BioMarin Pharmaceutical Inc said on Thursday the U.S. Food and Drug Administration had rejected the company's drug to treat a rare muscle-wasting disorder. The rejection comes after a panel of independent advisers to the FDA indicated that efficacy data on the drug was not persuasive enough for an approval. There is currently no FDA- approved therapy to...

  • FDA rejects BioMarin's muscle-wasting disorder drug Thursday, 14 Jan 2016 | 8:37 AM ET

    Jan 14- BioMarin Pharmaceutical Inc said on Thursday the U.S. Food and Drug Administration had rejected its drug to treat a rare muscle-wasting disorder.