|FDA authorizes, with special controls, a direct-to-consumer test that reports three mutations in the BRCA breast cancer genes.|
|FDA authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It is the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population.|
Read the press release.
|Statement from FDA Commissioner on Essure.|
|FDA Commissioner Scott Gottlieb, M.D., outlines the steps FDA has taken, to date, regarding Essure, and the additional steps that are underway.|
Read the statement.
|FDA approves new HIV treatment for patients who have limited treatment options.|
|FDA approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV). Trogarzo is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.|
Learn more about this new treatment.
Visit FDA's Women and HIV webpage.
|FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world.|
|FDA expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.|
Learn more about this approval.
|FDA warns of fraudulent and unapproved flu products.|
|As part of the FDA’s ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu. This year’s severe flu season raises new concerns about the potential for consumers to be lured into buying unproven flu treatments, and even worse, buying counterfeit antivirals online from websites that appear to be legitimate online pharmacies.|
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