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Government Agencies FDA

  • FDA's Scott Gottlieb: Opioid addiction is FDA's biggest crisis now

    Dr. Scott Gottlieb, FDA commissioner, talks about the role the FDA will play in helping to reduce opioid addiction in the U.S.

  • FDA's Scott Gottlieb: Investors need 'clarity' on policy

    Dr. Scott Gottlieb, FDA commissioner, discusses the FDA's mission, including ramping up the process of getting drugs approved.

  • FDA's Scott Gottlieb: Taking steps to bring more competition to pharma space

    Dr. Scott Gottlieb, FDA commissioner, discusses how the FDA intends to help bring down drug costs by removing obstacles that block generic versions from entering the marketplace.

  • Sarepta's drug, Exondys 51, generated sales of $35 million in the second quarter ended June 30, the company said on Wednesday. The result well exceeded analysts' average expectation of $22.9 million, according to Cowen& Co.. Exondys 51 was approved by the U.S. Food and Drug Administration in September.

  • A former Googler is hoping to use machine learning technology to prevent sudden cardiac death.

  • A scientist at Vertex Pharmaceuticals works in her laboratory in San Diego.

    Vertex is attempting to expand treatment options to about 40 percent of cystic fibrosis patients.

  • July 18- Gilead Sciences Inc said on Tuesday that the U.S. Food and Drug Administration approved its hepatitis C drug for patients who had failed to respond to prior treatments. Vosevi is the first drug to be approved for hepatitis C patients already treated with Sovaldi or other drugs, which inhibit a protein called NS5A, the FDA said in a separate release.

  • A collection of expired prescription drugs ready for disposal.

    A pharmaceutical company will occasionally extend the expiration dates of its own products because of shortages, ProPublica reports.

  • July 17- The U.S. Food and Drug Administration on Monday approved Puma Biotechnology Inc's experimental breast cancer drug that lowers the risk of the disease returning after initial treatment. The stock has so far more than doubled in value since May when the FDA said in a preliminary review that Puma Biotech's drug, neratinib, appeared to be effective.

  • July 17- The U.S. Food and Drug Administration on Monday approved Puma Biotechnology Inc's experimental breast cancer drug that lowers the risk of the disease returning after initial treatment. Puma Biotech's drug the first treatment of its kind is designed to treat early-stage breast cancer in patients with the HER2 genetic mutation whose tumor has been...

  • July 17- The U.S. Food and Drug Administration on Monday approved Puma Biotechnology Inc's lead drug to treat patients with a type of early-stage breast cancer.

  • A spa director at Revive Medical Spa, sets up a CoolSculpting machine for a client in Fayetteville, Ark., July 7, 2017.

    A medical practice can earn $200,000 in "gross profit" a year by seeing two CoolSculpting patients a week, N.Y. Times reports.

  • Magellan's devices are the only lead testing products cleared by the FDA and account for about half of all lead tests in the United States. In its report, the FDA listed certain observations that may be in violation of federal law, including concerns that design validation studies on some devices did not ensure they work the way they are intended to.

  • Magellan's devices are the only lead testing products cleared by the FDA and account for about half of all lead tests in the United States. In its report, the FDA listed certain observations that may be in violation of federal law, including concerns that design validation studies on some devices did not ensure they work the way they are intended to.

  • It urges the FDA to bolster a public health approach that already has resulted in one painkiller being pulled from the market. Last week, the maker of opioid painkiller Opana ER withdrew its drug at the FDA's request following a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to sharing needles to inject the pills. Aaron Kesselheim of Harvard...

  • July 13- The U.S. Food and Drug Administration on Thursday raised concerns about Meridian Bioscience Inc's facility that manufactures its testing device nearly two months after the regulator warned the tests underestimate lead levels in blood. The FDA issued a Form 483 to Magellan Diagnostics, which was bought by Meridian Bioscience in 2016 for $66 million,...

  • The panel unanimously recommended that the Food and Drug Administration approve the drug, tisagenlecleucel, for patients ages 3 to 25 with relapsed B-cell acute lymphoblastic leukemia, the most common form of U.S childhood cancer. Brian Rini, a panelist and physician at Cleveland Clinic Taussig Cancer Institute. The FDA is not obliged to follow the...

  • SILVER SPRING, Md.— The Latest on a Food and Drug Administration panel's review of a gene therapy treatment:. The Food and Drug Administration advisory panel voted 10-0 on Wednesday to recommend approval of the treatment developed by the University of Pennsylvania and Novartis Corp. The one-time treatment would be for children and young adults with advanced...

  • The legislation approved Wednesday by the Republican-controlled Appropriations Committee would prevent the FDA from requiring retroactive safety reviews of e-cigarettes already on the market. The development comes as the Trump administration has delayed enforcement of the new FDA rule and the e-cigarette industry is hopeful that efforts to roll...

  • A Medtronic worker assembles a device that is inserted into a heart pacemaker.

    A current draft compels the F.D.A. to speed medical devices onto the market — and into patients — faster than ever, N.Y. Times reports.