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Press releases from FDA
Updated: 33 min 52 sec ago

FDA approves novel preventive treatment for migraine

Thu, 2018-05-17 18:44
FDA approves Aimovig for the preventive treatment of migraine. Aimovig works by blocking the activity of a molecule that is involved in migraine attacks.

FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal, amid continued concerns around youth access to products

Thu, 2018-05-17 09:18
FDA continued to take important steps to address youth use of e-cigarettes by sending official requests for information to four e-cigarette makers requiring them to submit important documents to better understand the youth appeal.

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

Wed, 2018-05-16 15:23
FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.

FDA approves first epoetin alfa biosimilar for the treatment of anemia

Tue, 2018-05-15 11:00
FDA approves Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

Fri, 2018-05-11 15:32
FDA approves Gilenya (fingolimod) to treat multiple sclerosis MS in children age 10 and older. This is the first FDA approval of a drug to treat MS in pediatric patients

Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices

Fri, 2018-05-11 15:00
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices

FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan

Thu, 2018-05-10 09:18
FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan

FDA seeks permanent injunctions against two stem cell clinics

Wed, 2018-05-09 16:37
FDA is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval

Declaración del Dr. Scott Gottlieb, MD, comisionado de la FDA, sobre los beneficios de la aprobación del etiquetado en los menús para la salud pública

Mon, 2018-05-07 15:50
beneficios de la aprobación del etiquetado en los menús para la salud pública

FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding

Mon, 2018-05-07 12:39
FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding

Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling

Mon, 2018-05-07 08:43
Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling

FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer

Fri, 2018-05-04 11:27
FDA approves Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer

FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies

Tue, 2018-05-01 09:29
FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Committee on Appropriations on FDA’s Fiscal Year 2019 budget

Tue, 2018-04-24 14:09
FDA Commissioner Scott Gottlieb, M.D. remarks to a U.S. Senate Subcommittee on Appropriations on the FDA’s Fiscal Year 2019 budget

Statement from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes

Tue, 2018-04-24 09:21
FDA announces several new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes.

FDA authorizes new use of test, first to identify the emerging pathogen <i>Candida auris</i>

Fri, 2018-04-20 14:47
FDA authorized the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage more widespread innovation and development of new treatments for opioid use disorder

Fri, 2018-04-20 09:09
FDA announces new steps to encourage more widespread innovation and development of new treatments for opioid use disorder

FDA takes new steps to advance the development of innovative products for treating opioid use disorder

Fri, 2018-04-20 09:05
FDA announces new steps to encourage and support the development of treatment options for people with opioid use disorder

Federal judge enters consent decree against Cantrell Drug Company

Thu, 2018-04-19 17:49
Cantrell Drug Company prohibited from manufacturing and distributing sterile drug products in violation of the law

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