Istituzioni

FDA approves new treatment for pediatric patients with type 2 diabetes

Food and Drug Administration - 6 ore 35 min ago
: FDA approves Victoza (liraglutide) injection for pediatric patients with type 2 diabetes. Victoza creates the same effect as GLP-1 receptor protein and is the first non-insulin drug approved since metformin in 2000.
Categorie: Istituzioni

Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices

Food and Drug Administration - 6 ore 35 min ago
Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices
Categorie: Istituzioni

Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys

Food and Drug Administration - 6 ore 35 min ago
FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys
Categorie: Istituzioni

FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems as part of commitment to continuing a strong oversight of e-cigarettes

Food and Drug Administration - 6 ore 35 min ago
FDA finalizes guidance for manufacturers submitting premarket tobacco product applications for electronic nicotine delivery systems, such as e-cigarettes or “vapes.”
Categorie: Istituzioni

FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

Food and Drug Administration - 6 ore 35 min ago
FDA approved Polivy in combination with the chemotherapy bendamustine and a rituximab product to treat adult patients with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies.
Categorie: Istituzioni

FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age

Food and Drug Administration - 6 ore 35 min ago
FDA permits marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS.
Categorie: Istituzioni

Remarks on World Food Safety Day: ‘Food Safety Is Everyone’s Business’

Food and Drug Administration - 6 ore 35 min ago
Remarks from Deputy Commissioner Frank Yiannas on World Food Safety Day
Categorie: Istituzioni

FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalf

Food and Drug Administration - 6 ore 35 min ago
FDA and FTC cite four firms that make or sell several flavored e-liquid products for violations related to online posts by social media influencers on each company’s behalf.
Categorie: Istituzioni

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

Food and Drug Administration - 6 ore 35 min ago
FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices
Categorie: Istituzioni

FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks

Food and Drug Administration - 6 ore 35 min ago
FDA approves new use of Emgality to treat episodic cluster headache
Categorie: Istituzioni

Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law

Food and Drug Administration - 6 ore 35 min ago
Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law
Categorie: Istituzioni

FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer

Food and Drug Administration - 6 ore 35 min ago
The FDA Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer.
Categorie: Istituzioni

Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine

Food and Drug Administration - 6 ore 35 min ago
Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine
Categorie: Istituzioni

FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions

Food and Drug Administration - 6 ore 35 min ago
FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions
Categorie: Istituzioni

FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

Food and Drug Administration - 6 ore 35 min ago
FDA Warns Against the Use of Unauthorized Devices for Diabetes Management
Categorie: Istituzioni

FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots

Food and Drug Administration - 6 ore 35 min ago
The FDA approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older.
Categorie: Istituzioni

Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of brea

Food and Drug Administration - 6 ore 35 min ago
Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants
Categorie: Istituzioni

First FDA-approved vaccine for the prevention of dengue disease in endemic regions

Food and Drug Administration - 6 ore 35 min ago
FDA approves first vaccine for prevention of dengue disease in people ages 9-16 who have laboratory-confirmed previous dengue infection and live in endemic areas, such as the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.
Categorie: Istituzioni

FDA Statement on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues

Food and Drug Administration - 6 ore 35 min ago
FDA describes the ongoing investigation into the ARB class impurities and agency’s steps to address the root causes of the safety issues
Categorie: Istituzioni