Food and Drug Administration

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Press releases from FDA
Aggiornato: 15 ore 57 min fa

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

Gi, 24/05/2018 - 23:43
The FDA today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU).
Categorie: Istituzioni

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

Gi, 24/05/2018 - 22:11
FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures
Categorie: Istituzioni

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

Me, 23/05/2018 - 15:20
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.
Categorie: Istituzioni

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

Ma, 22/05/2018 - 18:19
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
Categorie: Istituzioni

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

Ma, 22/05/2018 - 16:01
FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses
Categorie: Istituzioni

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

Lu, 21/05/2018 - 16:50
FDA approves Doptelet (avatrombopag) to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical procedure.
Categorie: Istituzioni

FDA approves novel preventive treatment for migraine

Ve, 18/05/2018 - 01:44
FDA approves Aimovig for the preventive treatment of migraine. Aimovig works by blocking the activity of a molecule that is involved in migraine attacks.
Categorie: Istituzioni

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

Gi, 17/05/2018 - 16:18
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.
Categorie: Istituzioni

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

Me, 16/05/2018 - 22:23
FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.
Categorie: Istituzioni

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

Me, 16/05/2018 - 22:23
FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.
Categorie: Istituzioni

FDA approves first epoetin alfa biosimilar for the treatment of anemia

Ma, 15/05/2018 - 18:00
FDA approves Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia
Categorie: Istituzioni

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

Ve, 11/05/2018 - 22:32
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
Categorie: Istituzioni

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

Ve, 11/05/2018 - 22:00
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices
Categorie: Istituzioni

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

Gi, 10/05/2018 - 16:18
FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan
Categorie: Istituzioni

FDA seeks permanent injunctions against two stem cell clinics

Me, 09/05/2018 - 23:37
FDA is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval
Categorie: Istituzioni

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

Lu, 07/05/2018 - 22:50
beneficios de la aprobación del etiquetado en los menús para la salud pública
Categorie: Istituzioni

FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding

Lu, 07/05/2018 - 19:39
FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding
Categorie: Istituzioni

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

Lu, 07/05/2018 - 15:43
Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling
Categorie: Istituzioni

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

Ve, 04/05/2018 - 18:27
FDA approves Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer
Categorie: Istituzioni