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Press releases from FDA
Updated: 14 min 46 sec ago

FDA warns of potential contamination in multiple brands of drugs, dietary supplements

Fri, 2017-08-11 14:34
The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection.

FDA to expand public education campaign to focus on prevention of youth e-cigarette use

Tue, 2017-08-08 09:00
Today, the U.S. Food and Drug Administration announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by kids. The agency plans to expand its “The Real Cost” public education campaign to include messaging to teens about the dangers of using these products this fall while developing a full-scale campaign to launch in 2018. These efforts are part of the agency’s new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers associated with using all tobacco products. It is the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS.

Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions

Fri, 2017-08-04 09:17
U.S. District Judge Robert J. Shelby entered a consent decree of permanent injunction yesterday between the United States and Isomeric Pharmacy Solutions of Salt Lake City, Utah, two of the company’s co-owners, William O. Richardson and Rachael S. Cruz, and chief operating officer Jeffery D. Brown.

FDA approves Mavyret for Hepatitis C

Thu, 2017-08-03 14:06
The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.

FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia

Thu, 2017-08-03 08:09
The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine.

FDA approves treatment for chronic graft versus host disease

Wed, 2017-08-02 10:30
The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.

FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia

Tue, 2017-08-01 10:10
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.

FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

Fri, 2017-07-28 08:55
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

Thu, 2017-07-20 12:44
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

Wed, 2017-07-19 08:46
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

Tue, 2017-07-18 13:23
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

Mon, 2017-07-17 15:42
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

Thu, 2017-07-13 12:24
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

Thu, 2017-07-13 09:30
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

Fri, 2017-07-07 10:16
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

Thu, 2017-07-06 09:19
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.

FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy

Mon, 2017-07-03 12:17
Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors.

Federal judge orders New York smoked fish company to stop sales due to food safety violations

Fri, 2017-06-30 13:03
A New York smoked fish company has been ordered by a federal court to stop selling its products, which were produced in a facility that was contaminated with Listeria monocytogenes (L. mono), until it can comply with food safety regulations.

FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas

Thu, 2017-06-29 15:44
The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).

FDA unveils plan to eliminate orphan designation backlog

Thu, 2017-06-29 08:38
Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony before a Senate subcommittee.

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