News & Events

Subscribe to News & Events feed
Press releases from FDA
Updated: 1 hour 59 min ago

FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

Tue, 2018-03-20 13:31
FDA approves Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products

Tue, 2018-03-20 07:59
FDA takes steps to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products.

Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels

Thu, 2018-03-15 08:11
FDA takes pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels.

FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk

Fri, 2018-03-09 09:32
FDA has issued warning letters to Olympus, FujiFilm and Pentax, for failing to comply with section 522 orders on postmarket surveillance studies for duodenoscopes

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response...

Thu, 2018-03-08 11:45
Commissioner remarks as prepared for testimony at the hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.”

Statement from FDA Commissioner Scott Gottlieb, M.D., on effort to help bolster U.S. shellfish market by taking mutually beneficial steps to resume shellfish trade with the EU

Thu, 2018-03-08 09:53
FDA announces proposed shellfish equivalence determination with the EU that will create new market access for U.S. exporters as well as make a wider selection of healthy and safe shellfish options available to consumers. It will also assure American consumers that imported molluscan shellfish from Europe is as safe as what we produce in the U.S.

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed

Wed, 2018-03-07 13:52
The FDA is actively evaluating a significant increase in the number of medical device reports submitted to the agency on the Essure device from October to December 2017

FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply

Tue, 2018-03-06 18:06
FDA approves first tests to screen for tickborne parasite in blood donations

FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

Tue, 2018-03-06 12:52
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

FDA approves new HIV treatment for patients who have limited treatment options

Tue, 2018-03-06 12:13
The 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.

FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes

Tue, 2018-03-06 08:44
FDA has authorized 23andMe to market a consumer test that reports only 3 out of more than 1,000 known mutations in BRCA genes

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s commitment to modernizing food and nutrition programs

Mon, 2018-03-05 12:42
FDA announces commitment to modernize and streamline our food and nutrition programs to make sure that our investments of new and existing resources achieve their intended public health goals.

FDA warns of fraudulent and unapproved flu products

Fri, 2018-03-02 12:41
FDA warns of fraudulent and unapproved flu products

FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution

Thu, 2018-03-01 16:34
FDA is alerting not to use drug products produced by Cantrell Drug Company that were distributed nationwide.

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance implementation of the new consumer Nutrition Facts label for foods

Thu, 2018-03-01 08:05
Americans rely on the U.S. Food and Drug Administration to ensure that food labels contain updated nutritional information to help them make more informed food choices that lead to better health for themselves and their families. I’ve made nutrition one of my top priorities, and ensuring that consumers have accurate and science-based information concerning the link between diet and chronic diseases like diabetes, obesity and heart disease is part of that commitment. We need to advance new ways to use the science we’re learning about diet and nutrition as tools for reducing the burden of disease. Our update to the iconic Nutrition Facts label includes significant changes to help consumers make more informed dietary choices, and we are already seeing the new label on many products.

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s ongoing efforts to help improve effectiveness of influenza vaccines

Mon, 2018-02-26 11:42
FDA provides update on flu vaccines during this severe flu season

FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid

Wed, 2018-02-21 10:20
FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid

FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing

Fri, 2018-02-16 15:48
FDA approves drug to reduce the risk of stage III non-small cell lung cancer progressing

Statement from FDA Commissioner Scott Gottlieb, M.D. on the efficacy of the 2017-2018 influenza vaccine

Thu, 2018-02-15 15:20
FDA provides update on flu vaccines during this severe flu season

Pages