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Press releases from FDA
Updated: 1 hour 49 min ago

FDA approves first artificial iris

Wed, 2018-05-30 14:13
FDA approves first artificial iris, a surgically implanted device to treat aniridia or other damage to the iris

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

Wed, 2018-05-30 13:43
FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak

Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act

Wed, 2018-05-30 11:20
FDA stands ready to implement the Right to Try Act in a way that achieves Congress’ intent to promote access and protect patients

FDA approves new treatment for moderately to severely active ulcerative colitis

Wed, 2018-05-30 11:12
FDA today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.

As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion

Wed, 2018-05-30 08:17
As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion

FDA approves a new treatment for PKU, a rare and serious genetic disease

Thu, 2018-05-24 16:43
The FDA today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU).

FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures

Thu, 2018-05-24 15:11
FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

Wed, 2018-05-23 08:20
OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

Tue, 2018-05-22 11:19
The FDA is announcing three new efforts as part of a comprehensive set of actions to advance the FDA’s framework for sun protection products ahead of this coming summer

FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses

Tue, 2018-05-22 09:01
FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses

FDA approves new drug for patients with chronic liver disease who have low blood platelets and are undergoing a medical procedure

Mon, 2018-05-21 09:50
FDA approves Doptelet (avatrombopag) to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical procedure.

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

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