BooksTestimonialsInterviewsLibraryArticlesShop Here 

In the News

FDA updates blood donor deferral policy to reflect the most current scientific evidence and continue to ensure the safety of the U.S. blood supply

FDA News - Mon, 12/21/2015 - 10:55
Today the U.S. Food and Drug Administration issued a final guidance outlining updated donor deferral recommendations that appropriately protect the U.S. blood supply by reducing the risk of transmitting human immunodeficiency virus (HIV) infection.
Categories: In the News

FDA permits marketing of fecal continence restoration system

FDA News - Fri, 12/18/2015 - 09:13
The U.S. Food and Drug Administration today approved the Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.
Categories: In the News

FDA proposes tanning bed age restrictions and other important safety measures

FDA News - Fri, 12/18/2015 - 07:57
Today, the U.S. Food and Drug Administration announced important proposed steps ‎to protect public health by preventing the use of sunlamp products (also commonly known as indoor tanning beds) by minors and reducing the risk of using these devices for adults. The FDA is committed to protecting public health by informing consumers of the risks of indoor tanning.
Categories: In the News

FDA approves wearable defibrillator for children at risk for sudden cardiac arrest

FDA News - Thu, 12/17/2015 - 12:37
The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.
Categories: In the News

FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes

FDA News - Wed, 12/16/2015 - 15:26
The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Categories: In the News

FDA approves Bridion to reverse effects of neuromuscular blocking drugs used during surgery

FDA News - Tue, 12/15/2015 - 14:14
The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.
Categories: In the News

FDA takes action against Vermont dairy farm for illegally administering drugs to cattle

FDA News - Tue, 12/15/2015 - 11:59
Today, the U.S. Department of Justice entered a consent decree of permanent injunction in the District of Vermont against the Correia Family Limited Partnership, doing business as Wynsum Holsteins, a dairy farm located in West Addison, Vermont, and its partners, Anthony Correia, Barbara Correia and Stephen Correia. The decree accompanies a complaint filed at the request of the U.S. Food and Drug Administration.
Categories: In the News

FDA approves new oral therapy to treat ALK-positive lung cancer

FDA News - Fri, 12/11/2015 - 12:03
The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).
Categories: In the News

FDA approves first emergency treatment for overdose of certain types of chemotherapy

FDA News - Fri, 12/11/2015 - 11:05
The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.
Categories: In the News

FDA allows marketing of cooling cap to reduce hair loss during chemotherapy

FDA News - Tue, 12/08/2015 - 15:07
Today, the U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy.
Categories: In the News

FDA approves first recombinant von Willebrand factor to treat bleeding episodes

FDA News - Tue, 12/08/2015 - 13:44
The U.S. Food and Drug Administration today approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with VWD.
Categories: In the News

FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients

FDA News - Tue, 12/08/2015 - 09:43
Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.
Categories: In the News

FDA clears military traumatic wound dressing for use in the civilian population

FDA News - Mon, 12/07/2015 - 15:49
Today, the U.S. Food and Drug Administration cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication for use from use by the military only to use in adults and adolescents in the general population.
Categories: In the News
Syndicate content