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.
Category Archives: Drug Safety Information Podcasts
FDA acts to protect children from illegal tobacco sales
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.
FDA issues two draft guidance documents to facilitate investigational medical device studies in humans
The U.S. Food and Drug Administration today issued a draft guidance aimed at fostering early-stage development of medical devices within the United States.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.
FDA approves first cord blood product
The U.S. Food and Drug Administration today approved HEMACORD, the first licensed hematopoietic progenitor cells-cord (HPC-C) cell therapy.
FDA Statement on Makena
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.
FDA launches website on safe disposal of used needles and other “sharps”
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.
FDA approves Erbitux to treat late-stage head and neck cancer
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.
FDA approves Xarelto to prevent stroke in people with common type of abnormal heart rhythm
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).
FDA: 35 innovative new drugs approved in fiscal year 2011
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 first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.
FDA approves first artificial aortic heart valve placed without open-heart surgery
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.