×

Government Agencies FDA

  • Dec 1- The U.S. Food and Drug Administration on Friday approved Mylan NV's biosimilar of Roche's blockbuster breast cancer treatment Herceptin.

  • Dec 1- Indivior's experimental drug to help fight America's growing opioid addiction crisis was approved by the U.S. Food and Drug Administration late on Thursday, boosting its sales prospects as competitors threaten revenues from an older product. Shares in the London- listed company, which specializes in addiction treatment, were up 10.9 percent at 411...

  • CHICAGO, Nov 30- A test from Foundation Medicine Inc that can detect cancer-causing mutations in 324 genes has won approval from the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services, the agencies said. That includes Merck& Co Inc's Keytruda, which in May won FDA approval for use in patients whose tumors carry a specific genetic...

  • Nov 30- The U.S. Food and Drug Administration on Thursday cleared a device embedded in an Apple Inc watch band that monitors a user's heart rate, detects when something is amiss and prompts the user to take an electrocardiogram. The device, made by AliveCor, pairs the ability to take a personal 30 second electrocardiogram with a feature that uses artificial...

  • Nov 29- The U.S. Food and Drug Administration said on Wednesday it is considering measures to speed development of products that help people quit smoking, including easing requirements for approval of over-the-counter nicotine replacement therapies. Because their effectiveness is limited, the FDA wants to give consumers a wider range of options.

  • Mylan EpiPen

    The Food and Drug Administration announced guidance that potentially streamlines a path to market for generic copies of complex medicines.

  • NEW YORK, Nov 21- The U.S. Food and Drug Administration on Tuesday approved the first two-drug regimen to treat HIV, the virus that causes AIDS, aimed at lessening the side effect burden of current treatments that combine three or four medicines. Juluca belongs to GlaxoSmithKline Plc's majority-owned ViiV Healthcare, in which Pfizer Inc and Shionogi also have...

  • *FDA's Hemlibra approval comes with blood clot warning. ZURICH, Nov 16- The U.S. Food and Drug Administration on Thursday approved Roche's Hemlibra, a new medicine for hemophilia A that the Swiss drugmaker is counting on to help to offset eroding sales of older medicines going off patent. But the FDA slapped Roche's medicine with a black box warning, the most...

  • *FDA's Hemlibra approval comes with blood clot warning. ZURICH, Nov 16- The U.S. Food and Drug Administration on Thursday approved Roche's Hemlibra, a new medicine for haemophilia A that the Swiss drugmaker is counting on to help to offset eroding sales of older medicines going off patent. But the FDA slapped Roche's medicine with a black box warning, the most...

  • *FDA's Hemlibra approval comes with blood clot warning. ZURICH, Nov 16- The U.S. Food and Drug Administration on Thursday approved Roche's Hemlibra, a new medicine for haemophilia A that the Swiss drugmaker is counting on to help to offset eroding sales of older medicines going off patent. But the FDA slapped Roche's medicine with a black box warning for blood...

  • *FDA's Hemlibra approval comes with blood clot warning. ZURICH, Nov 16- The U.S. Food and Drug Administration on Thursday approved Roche's Hemlibra, a new medicine for hemophilia A that the Swiss drugmaker is counting on to help to offset eroding sales of older medicines going off patent. But the FDA slapped Roche's medicine with a black box warning for blood clots,...

  • *FDA's Hemlibra approval comes with blood clot warning. ZURICH, Nov 16- The U.S. Food and Drug Administration on Thursday approved Roche's Hemlibra, a new medicine for hemophilia A that the Swiss drugmaker is counting on to help to offset eroding sales of older medicines going off patent. But the FDA slapped Roche's medicine with a black box warning for blood clots,...

  • *FDA's Hemlibra approval comes with blood clot warning. ZURICH, Nov 16- The U.S. Food and Drug Administration on Thursday approved Roche's Hemlibra, a new medicine for haemophilia A that the Swiss drugmaker is counting on to help to offset eroding sales of older medicines going off patent. But the FDA slapped Roche's medicine with a black box warning for blood...

  • Nov 15- The U.S. Food and Drug Administration on Wednesday cleared for use an electrical nerve stimulator designed to reduce the symptoms of opioid withdrawal. The device, made by privately held Innovative Health Solutions Inc., is placed behind the patient's ear for up to five days during the acute withdrawal phase. The FDA authorized the device, known as NSS-2...

  • Dr. Scott Gottlieb

    Food and Drug Administration Commissioner Scott Gottlieb says kratom has addictive qualities.

  • Shatterproof CEO: Battling the opioid crisis

    There's a big gap between proven research and implementing it into the system, says Gary Mendell, Shatterproof CEO, providing insight to treating patients for opioid addiction. It's a disease, says Mendell.

  • FDA commissioner warns consumers about using kratom to treat opioid addiction

    Scott Gottlieb, Food and Drug Administration commissioner, shares his concerns about herbal supplement kratom and the agency's steps to seek regulatory control.

  • Nov 14- Anglo-Swedish pharmaceutical firm AstraZeneca Plc on Tuesday said the U.S. Food and Drug Administration approved its drug benralizumab, as an add-on treatment for patients with severe asthma aged 12 years and older. The asthma drug will be marketed under the name Fasenra in the United States. Fasenra is under regulatory review in the EU, Japan and...

  • Kratom, a natural plant grown in parts of Asia, is available in the United States as a dietary supplement and the FDA has said kratom products have been crossing into the U.S. in increasing amounts. In 2012 and 2014 the FDA placed import alerts on kratom, allowing FDA agents to detain the products at the border. The FDA declined to say over what period the 36 deaths...

  • Kratom, which is a naturally growing plant in Thailand, Malaysia, Indonesia and Papua New Guinea, is increasingly being used to treat pain, anxiety, depression and opioid addiction in the United States, at a time when the country is already battling an ongoing opioid epidemic. Kratom has similar effects to narcotics like opioids and carries similar risks of abuse,...