The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.
Category Archives: Drug Safety Information Podcasts
FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year
roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction,
at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to
efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an appropriate
balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also
providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products.
The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.
FDA clears first neonatal magnetic resonance imaging device
Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU).
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Funding Awards to States for FDA Food Safety Modernization Act (FSMA) Produce Safety Implementation
More than 3,000 Americans are estimated to die each year from foodborne illnesses and many more are hospitalized and sickened. Yet most of these illnesses and deaths are preventable. While the U.S. has one of the safest food supplies in the world, Congress entrusted the FDA with new authorities and resources – as part of the FDA Food Safety Modernization Act (FSMA) – to update and strengthen the FDA’s risk-based approach to the oversight of food safety.
FDA approves Vosevi for Hepatitis C
The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.
FDA approves new treatment to reduce the risk of breast cancer returning
The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.
Statement from FDA Commissioner Scott Gottlieb, M.D., on National Academies of Sciences, Engineering, and Medicine report on pain management and prescription opioid abuse
In March 2016, the FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to outline the state of the science regarding prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management. We greatly appreciate all the work done by NASEM over the past year to produce the comprehensive report released today, which includes recommendations for the FDA and others on this important issue.
Statement from Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health on the status of FDA’s investigation into inaccurate results from certain lead tests
On May 17, the U.S. Food and Drug Administration warned Americans that Magellan Diagnostics’ LeadCare test systems performed on blood drawn from the vein (venous) may provide inaccurate results.
FDA approves new treatment for sickle cell disease
The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder.
Federal judge enters consent decree against Alabama compounder Medistat
U.S. District Judge William H. Steele entered a consent decree of permanent injunction yesterday between the United States and Medistat RX LLC of Foley, Alabama, the company’s co-owners, Mark D. Acker and Timothy L. Fickling, and quality manager and pharmacist-in-charge V. Elaine Waller.