This week, 65 representatives of health and regulatory agencies from 22 countries attended the International Tobacco Regulators’ Conference, hosted by the U.S. Food and Drug Administration and the World Health Organization Tobacco Free Initiative.
The U.S. Food and Drug Administration today approved Jakafi (ruxolitinib), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis.
The U.S. Food and Drug Administration sent Warning Letters to more than 1,200 retailers, the majority of which respond to violations relating to selling tobacco to minors, as part of its ongoing effort to reduce tobacco use among children.
The U.S. Food and Drug Administration today issued a draft guidance aimed at fostering early-stage development of medical devices within the United States. Doing early-stage development is important to help stimulate U.S.-based innovation and contribute to medical research.
The U.S. Food and Drug Administration today approved HEMACORD, the first licensed hematopoietic progenitor cells-cord (HPC-C) cell therapy.
FDA approved Makena (hydroxyprogesterone caproate) in February 2011 for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth.
The U.S. Food and Drug Administration today launched a new website for patients and caregivers on the safe disposal of needles and other so-called “sharps” that are used at home, at work and while traveling.
The U.S. Food and Drug Administration today approved Erbitux (cetuximab) for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer.
The U.S. Food and Drug Administration today approved the anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation).
Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the […]
The U.S. Food and Drug Administration today approved the first artificial heart valve that can replace an aortic heart valve damaged by senile aortic valve stenosis without open-heart surgery.
The U.S. Food and Drug Administration has approved a stent graft system that provides patients with small arteries the option of less invasive surgery to repair their potentially life-threatening abdominal aortic aneurysm.
The U.S. Food and Drug Administration today approved the first artificial heart valve that can replace an aortic heart valve damaged by senile aortic valve stenosis without open-heart surgery.
The U.S. Food and Drug Administration (FDA) today announced that Raymond L. Martin, a sole proprietor operating Corner View Dairies, located in Lyons, NY, has signed a consent decree of permanent injunction. The decree prohibits Mr. Martin from selling animals with illegal levels of animal drugs and from administering drugs to animals without proper record-keeping […]
The Food and Drug Administration (FDA) is warning consumers not to eat Turkish pine nuts purchased from unlabeled plastic bulk containers at Wegmans Food Markets, Inc. or any food items they may have prepared using the bulk Turkish pine nuts, such as pesto, salads, or baked goods.
The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernize and improve the ways drugs […]
The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder.
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United […]
U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warrant issued by the U.S. District Court for the Northern District of Illinois.