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  • Imbruvica gains approval for treating chronic lymphocytic leukemia

    Regulatory
    Amanda Rupp | Jun 2, 2016

    AbbVie, a worldwide biopharmaceutical company, recently announced that officials at the European Commission (EC) have approved Imbruvica to be used as a first-line treatment option for chronic lymphocytic leukemia (CLL).

  • CHMP gives positive opinion of Zepatier tablet

    Regulatory
    Amanda Rupp | Jun 1, 2016

    The Committee for Medicine Products for Human Use (CHMP) branch of the European Medicines Agencies (EMA) recently granted a positive opinion of Zepatier, a Merck product.

  • First buprenorphine implant treatment for opioid dependence earns FDA approval

    Regulatory
    Amanda Rupp | Jun 1, 2016

    Leaders at the U.S. Food and Drug Administration (FDA) recently granted approval of Probuphine, which is the first buprenorphine implant that is designed to treat opioid dependence.

  • AMA celebrates new nutrition labels highlighting sugar amounts

    Regulatory
    Amanda Rupp | May 26, 2016

    Leaders at the American Medical Association (AMA) recently congratulated the U.S. Food and Drug Administration (FDA) for modifying its Nutrition Facts Label to emphasize the sugar levels in food products.

  • AHA celebrates Senate bill supporting Electronic Health Records Incentive Programs

    Regulatory
    Amanda Rupp | May 22, 2016

    The American Heart Association recently applauded the draft legislation from the Senate that could end the 'all-or-nothing approach' and implement meaningful use of the Medicare and Medicaid Electronic Health Records Incentive Programs.

  • Safety event testing uses patient and family input

    Regulatory
    Amanda Rupp | May 21, 2016

    The Agency for Healthcare Research and Quality (AHRQ) has developed a program, called the Health Care Safety Hotline project, to improve the quality and safety of medical events for patients throughout the U.S.

  • American Heart Association launches BLS, ACLS courses for emergency response systems

    Regulatory
    Amanda Rupp | May 20, 2016

    The American Heart Association (AHA) recently opened its guidelines-compliant BLS and ACLS courses, which are designed to help attendees better recognize and implement the emergency response system in an emergency situation.

  • MedImmune gains Fast Track designation for flu treatment

    Regulatory
    Amanda Rupp | May 12, 2016

    MedImmune, the worldwide biologics research and development branch of AstraZeneca, recently gained Fast Track designation for its MEDI18852, an investigational human monoclonal antibody (mAb), from the U.S. Food and Drug Administration (FDA).

  • American Medical Association applauds FDA's new tobacco product rule

    Regulatory
    Amanda Rupp | May 12, 2016

    The American Medical Association (AMA) recently released a statement that celebrates the new rule from the U.S. Food and Drug Administration (FDA) about e-cigarettes and other tobacco products.

  • FDA finalizes new tobacco regulations

    Regulatory
    Amanda Rupp | May 6, 2016

    The U.S. Food and Drug Administration (FDA) recently finalized a new rule that effectively enforces its authority for regulating all tobacco products, including cigars, e-cigarettes, pipe and hookah tobacco.

  • FDA to improve menu labeling

    Regulatory
    Amanda Rupp | May 5, 2016

    Leaders at the American Heart Association (AHA) recently stated that giving authority to the U.S. Food and Drug Administration (FDA) to guide menu labeling will give consumers more information about their food.

  • FDA approves name change for Brintellix brand

    Regulatory
    Amanda Rupp | May 4, 2016

    The U.S. Food and Drug Administration (FDA) recently granted approval to a brand name change for Brintellix (vortioxetine), an antidepressant drug, which sounds similar to Brilinta (ticagrelor), an antiplatelet drug.

  • FDA publishes final guidance for menu labeling

    Regulatory
    Amanda Rupp | May 4, 2016

    Leaders at the U.S. Food and Drug Administration (FDA) recently published their final implementation date for restaurants to label menus, allowing consumers to improve their food choices to decrease the risk of developing cancer.

  • Hallucination, delusion drug for Parkinson’s patients receives FDA approval

    Regulatory
    Amanda Rupp | May 3, 2016

    The U.S. Food and Drug Administration (FDA) recently granted approval for Nuplazid (pimavanserin) tablets, which are the first treatment for the hallucinations and delusions that accompany the psychosis that some Parkinson’s patients experience.

  • Inflectra awarded FDA approval

    Regulatory
    Amanda Rupp | May 1, 2016

    Inflectra (infliximab-dyyb), which is a biosimilar of Remicade, recently earned approval from officials and leaders with the U.S. Food and Drug Administration (FDA).

  • AAFP announces MACRA recommendations

    Regulatory
    Amanda Rupp | May 1, 2016

    The American Academy of Family Physicians (AAFP) recently released its own recommendations for the incoming application of the Medicare Access and CHIP Reauthorization Act (MACRA).

  • AbbVie earns FDA approval for Viekira Pak

    Regulatory
    Amanda Rupp | Apr 29, 2016

    AbbVie, a worldwide biopharmaceutical company, recently announced that the U.S. Food and Drug Administration (FDA) has granted approval of the company’s Supplemental New Drug Application for the Viekira Pak.

  • AAFP questions diabetic testing supplies efficacy

    Regulatory
    Amanda Rupp | Apr 22, 2016

    The American Academy of Family Physicians (AAFP) recently expressed its concern that the heavy Medicare requirements for diabetic supplies prescriptions may affect unbranded diabetic testing supplies and patients’ health.

  • American Academy of Family Physicians urges Obama to extend FDA authority, increase tobacco regulations

    Regulatory
    Amanda Rupp | Apr 21, 2016

    The American Academy of Family Physicians (AAFP) recently included itself among 29 other organizations that are pushing President Barack Obama to give the U.S. Food and Drug Administration (FDA) more authority over tobacco regulation.

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