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Government Agencies FDA

  • April 18- Bioelectronic healthcare company electroCore LLC said on Tuesday that the U.S. Food and Drug Administration had approved its hand-held device to treat cluster headaches. The company anticipates the product will be available in the United States in the third quarter. The device, which can be self-administered, is already approved for use in South...

  • April 17- Genentech, a unit of Swiss drugmaker Roche Holding AG, said on Monday it got approval from the U.S. Food and Drug Administration for its already approved immunotherapy drug, Tecentriq, to treat advanced bladder cancer. Tecentriq, also known as atezolizumab, received the go-ahead under the FDA's accelerated approval program as a first-line treatment...

  • WASHINGTON, April 14- The U.S. Food and Drug Administration on Friday declined to approve a new drug for rheumatoid arthritis made by Eli Lilly and Co and partner Incyte Corp, the companies said on Friday. FDA indicated that additional clinical data was needed to determine the most appropriate doses of the drug, Olumiant, known also as baricitinib, and to further...

  • The FDA, which said the company failed to disclose at least one death associated with one of the devices, said an inspection of the company's facility in Sylmar, California, raised questions about the safety of several implantable defibrillators and its Merlinzhome monitor, which allows doctors to care remotely for patients with cardiac devices.

  • April 13- The U.S. Food and Drug Administration has raised concerns over manufacturing controls at a Teva Pharmaceutical Industries plant in China, Israel's biggest company said in a regulatory filing on Thursday. Teva said the FDA's warning letter, which it received on April 10, stemmed from a regulatory inspection of the plant in September.

  • April 11- The U.S. Food and Drug Administration approved Neurocrine Biosciences Inc's drug to treat tardive dyskinesia, a side effect of antipsychotic medications characterized by uncontrolled movements of the face and body, the company said. Shares of the San Diego- based company were up about 18.5 percent to $49.15 after the closing bell on Tuesday.

  • April 11- The U.S. Food and Drug Administration on Tuesday approved Neurocrine Biosciences Inc's drug to treat tardive dyskinesia, a side effect of antipsychotic medications characterized by uncontrolled movement of the face and body, the company said. Last year, it said it would price Ingrezza at a net price of between $20,000 to $60,000 per year, depending on...

  • India- based drug manufacturing facilities have been criticized by the FDA in recent years for violating quality standards, as the agency increases oversight of key suppliers to the United States. "Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,"...

  • LONDON, April 10- The European Medicines Agency has had expressions of interest to host the London- based regulator from 21 of the 27 countries that will form the European Union once Britain leaves, revealing rivalry from Amsterdam to Zagreb for a prized institution. The European Medicines Agency, Europe's equivalent of the U.S. Food and Drug Administration, is...

  • Microchip technology.

    Implants might mean opening doors with a wave of your hand...and having your employer know where you are at all times, Recode reports.

  • The FDA said the tests are intended to provide genetic risk information but cannot determine a person's overall risk of developing a disease or condition. The company's genetic health risk reports work by testing saliva samples for more than 500,000 genetic variants whose presence or absence may be associated with the conditions approved by the FDA.

  • April 6- The U.S. Food and Drug Administration on Thursday agreed to allow genetic testing company 23 andMe to market tests directly to consumers for their predisposition to 10 diseases, including Parkinson's, Alzheimer's and Celiac disease. The FDA said the tests are intended to provide genetic risk information but cannot determine a person's overall risk...

  • April 5- Democratic senators questioned President Donald Trump's nominee to lead the U.S. Food and Drug Administration, Dr. Scott Gottlieb, over his ties to the pharmaceutical industry on Wednesday, with one citing "a level of discomfort" over his nomination. Democrats on the Senate Committee on Health, Education, Labor and Pensions questioned whether...

  • Scott Gottlieb

    Dr. Scott Gottlieb said he'd use his drug industry experience as a force to improve the FDA.

  • April 5- President Donald Trump's nominee to lead the U.S. Food and Drug Administration, Dr. Scott Gottlieb, was questioned about his ties to the pharmaceutical industry by Democrats on a key Senate committee on Wednesday ahead of a vote on whether to advance his nomination for a vote by the full Senate. Senator Chris Murphy of Connecticut said Democrats had "a...

  • April 5- The U.S. Food and Drug Administration needs Corbus Pharmaceuticals to show positive data from only one late-stage study on its experimental treatment for scleroderma to support a marketing application, the company said. The earliest the drug, anabasum, could win U.S. approval to treat scleroderma is in the latter half of 2020, if all went well, Chief...

  • April 3- Israel- based Teva Pharmaceutical Industries Ltd said the U.S. Food and Drug Administration had approved its drug to treat chorea stemming from Huntington's disease, a fatal degenerative disorder. The company said on Monday that the FDA approval was based on results from a late-stage study of the drug, Austedo, in reducing chorea in patients with...

  • LONDON, March 31- Philip Morris International said on Friday it has applied for pre-market approval of its iQOS heated tobacco product with the U.S. Food and Drug Administration. The world's largest international tobacco maker, owner of the Marlboro brand, said that if the FDA grants its request, its U.S. affiliate, Altria Group, would be responsible for selling...

  • UK- based Oxford BioMedica's shares get a lift. ZURICH, March 30- A new leukaemia treatment from Novartis for children and young adults will get priority review from the U.S. Food and Drug Administration, putting the Swiss drugmaker ahead of rivals working on similar cancer therapies. The FDA's announcement late Wednesday means the regulator plans to take...

  • *UK- based Oxford BioMedica's shares get a lift. ZURICH, March 30- A new leukemia treatment from Novartis for children and young adults will get priority review from the U.S. Food and Drug Administration, putting the Swiss drugmaker ahead of rivals working on similar cancer therapies. The FDA's announcement late Wednesday means the regulator plans to take action...