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News from U.S. Food and Drug Administration A wide array of domestic and global news stories; news topics include politics/government, business, technology, religion, sports/entertainment, science/nature, and health/lifestyle. Articles that appear in this section may be written in English or other languages.

Latest

12:56 ET FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes

The U.S. Food and Drug Administration today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in...


10:33 ET FDA launches public education campaign to encourage adult smokers trying to quit cigarettes

Today, the U.S. Food and Drug Administration announced an adult smoking cessation education campaign aimed at encouraging cigarette smokers to quit...


Dec 07, 2017, 12:57 ET El resfriado y la gripe: prevención, síntomas y tratamientos

In English. Los virus del resfriado y de la gripe siempre están flotando a nuestro alrededor. Entonces, ¿por qué parecemos ser especialmente...


Dec 07, 2017, 09:32 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation

Today we're announcing three new, significant policy documents to advance the FDA's approach to the development and proper oversight of innovative...


Dec 04, 2017, 10:58 ET Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices

Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a...


Dec 01, 2017, 10:40 ET FDA approves first biosimilar for the treatment of certain breast and stomach cancers

The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of...


Dec 01, 2017, 10:00 ET Día Mundial del SIDA: la seguridad de los alimentos es importante para las personas con VIH o SIDA

SILVER SPRING, Maryland, 1 de diciembre de 2017 /PRNewswire-HISPANIC PR WIRE/ -- El 1 de diciembre de 2017 es el Día Mundial del SIDA y la...


Dec 01, 2017, 10:00 ET World AIDS Day: Food Safety is Important for People with HIV or AIDS

Dec. 1 is World AIDS Day and the U.S. Food and Drug Administration (FDA) wants to remind those living with HIV or AIDS about our resource guide on...


Nov 30, 2017, 19:26 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA's efforts to promote more widespread innovation and access to opioid addiction treatments

With the approval today of a monthly formulation of the drug buprenorphine for the treatment of opioid use disorder, patients have access to a new...


Nov 30, 2017, 19:17 ET FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder

The U.S. Food and Drug Administration today approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of...


Nov 30, 2017, 16:53 ET Statement by FDA Commissioner Scott Gottlieb, M.D., updating on Puerto Rico related medical product shortages

While Puerto Rico is making progress in its effort to recover from the devastation left by the hurricanes, it remains a long process and there's a...


Nov 30, 2017, 16:45 ET FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers

The U.S. Food and Drug Administration today approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing...


Nov 30, 2017, 11:07 ET Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, "Implementing the 21st Century Cures Act: An Update from FDA and NIH"

Chairman Burgess, Ranking Member Greene, members of the subcommittee: Thank you for the opportunity to testify today on the anniversary of the 21st...


Nov 22, 2017, 11:29 ET FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients

The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device...


Nov 21, 2017, 16:38 ET FDA Warns Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel

The U.S. Food and Drug Administration is advising consumers not to use Limbrel, a product in capsule form currently being manufactured as a medical...


Nov 21, 2017, 14:01 ET FDA approves first two-drug regimen for certain patients with HIV

The U.S. Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults...


Nov 21, 2017, 09:51 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse

As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we're focused on taking actions that...


Nov 17, 2017, 14:46 ET FDA approves first telehealth option to program cochlear implants remotely

The U.S. Food and Drug Administration today approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System...


Nov 17, 2017, 09:45 ET Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

It's been nine weeks since Hurricane Maria made landfall on Puerto Rico and the island continues to struggle to recover from the devastation...


Nov 16, 2017, 16:02 ET FDA expands approval of Sutent to reduce the risk of kidney cancer returning

The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk...


Nov 16, 2017, 11:58 ET FDA approves new treatment to prevent bleeding in certain patients with hemophilia A

The U.S. Food and Drug Administration today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult...


Nov 16, 2017, 09:56 ET Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA's comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health

One of the most promising fields of science is the area of cell-based therapies and their use in regenerative medicine. These new technologies,...


Nov 16, 2017, 09:53 ET FDA announces comprehensive regenerative medicine policy framework

Today the U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine...


Nov 15, 2017, 12:48 ET FDA unveils a streamlined path for the authorization of tumor profiling tests alongside its latest product action

The U.S. Food and Drug Administration today authorized Memorial Sloan Kettering Cancer Center's (MSK) IMPACT (Integrated Mutation Profiling of...