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Press releases from FDA
Updated: 1 hour 11 min ago

FDA clears mammography device with option for patient-assisted compression

Fri, 2017-09-01 14:07
Today, the U.S. Food and Drug Administration cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.

FDA approves Mylotarg for treatment of acute myeloid leukemia

Fri, 2017-09-01 10:19
The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory).

Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma

Thu, 2017-08-31 10:08
Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma

FDA approval brings first gene therapy to the United States

Wed, 2017-08-30 09:41
The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.

FDA approves new antibacterial drug

Tue, 2017-08-29 16:56
The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.

FDA approves first U.S. treatment for Chagas disease

Tue, 2017-08-29 15:51
The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease.

Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine

Mon, 2017-08-28 07:56
One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair strategies is a tangible reality. This promise is reinforced by the strong commitment of the investment and scientific communities in exploring the potential applications across a wide range of vexing diseases and conditions, such as cancer, Parkinson’s disease, and diabetes, among many others.

FDA warns US Stem Cell Clinic of significant deviations

Mon, 2017-08-28 07:40
The U.S. Food and Drug Administration today posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida, and its Chief Scientific Officer Kristin Comella for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.

FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients

Mon, 2017-08-28 07:32
The U.S. Food and Drug Administration took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. On behalf of the FDA, on Friday, Aug. 25, 2017 the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact.

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s role in ensuring Americans have access to clear and consistent calorie and nutrition information; forthcoming guidance will provide greater clarity and certainty

Fri, 2017-08-25 08:29
As a doctor, father and the head of the U.S. Food & Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat. We serve as the nation’s expert on food labeling, which is why Congress entrusted us with the responsibility of crafting predictable, uniform federal standards that will benefit the health of families across America by ensuring access to essential calorie and nutrition information on food and menu labels.

Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is carefully evaluating prescription opioid medications approved to treat cough in children

Mon, 2017-08-21 08:31
There’s perhaps no more important mandate that we have at the FDA than safeguarding the health and safety of children. For that reason, I believe it’s important that parents and health care providers have the best information available to inform the decisions they make about a child’s health. There are few more common decisions that parents and providers are asked to make than the question of how to appropriately treat a child’s cough and cold symptoms. Sometimes symptoms can be severe enough that prescription medication is needed, but some of these medications pose their own risks – especially for younger children – because they may contain opioids. Other times medication might not be necessary at all.

FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection

Thu, 2017-08-17 14:52
As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection.

FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia

Thu, 2017-08-17 12:22
The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

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.

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