Istituzioni

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.

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.

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

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

FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

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

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

FDA approves new use of Emgality to treat episodic cluster headache

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

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.

FDA today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older.

FDA is soliciting feedback on the potential use of new authorities under the SUPPORT Act to require certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging.

FDA approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant.

FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality

FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections

FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results

FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea

U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction today between the United States and PharMedium Services, LLC, headquartered in Lake Forest, Illinois.

A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).