Medical News Today (Free subscription) | 3 hours ago
Talecris Biotherapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has granted a Priority Review of Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
New York Times (Free subscription) | 13 hours ago
A small drug company said it won approval Friday from the Food and Drug Administration to market the first drug meant to undo the effects of local dental anesthesia.
PharmaGossip (Free subscription) | yesterday
The Food and Drug Administration is withholding a list of Chinese heparin suppliers requested by congressional investigators looking into problems with tainted supplies of the blood thinner, saying confidentiality agreements prevent release of the companies' names. Members of Congress also are concerned that Chinese heparin manufacturers and their raw-material suppliers didn't...
Positive News Media (Free subscription) | yesterday
WASHINGTON, May 11 (Xinhua) -- The U.S. Food and Drug Administration approved on Friday the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
YubaNet.com (Free subscription) | 05/10/2008
The contraceptive patch Ortho-Evra exposes women to dangerous levels of the hormone estrogen, posing a possible two-fold increase in the risk of blood clots, and should be removed from the market within six months, Public Citizen told the Food and Drug Administration (FDA) in a petition filed today. Ongoing litigation has recently released unpublished studies that confirm the increased...
Medical News Today (Free subscription) | 05/10/2008
The US Food and Drug Administration (FDA) has found some hospitals and medical centers are still stocking potentially contaminated heparin among their supplies, showing that they failed to respond to recall notices and alerts about the blood thinner made by Baxter International.
Philadelphia Inquirer (Free subscription) | 05/10/2008
WASHINGTON - Closing loopholes in protections against mad cow disease, the Food and Drug Administration yesterday banned brains and other cattle parts that could carry the disease's infectious agent from use in cosmetics and dietary supplements.
Medical News Today (Free subscription) | 05/10/2008
Eli Lilly and Company (NYSE: LLY) announced that the United States Food and Drug Administration (FDA) has approved Strattera(R) (atomoxetine HCI) for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents.
Hugh Hewitt's TownHall Blog (Free subscription) | 05/10/2008
This is incredible: The Food and Drug Administration stepped up its heparin alerts to hundreds of hospitals, medical societies and pharmaceutical organizations on Friday after learning that some medical facilities...
Yeshiva World News (Free subscription) | 05/09/2008
The U.S. Food and Drug Administration today approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years. “Approval of this product for room [...]
www.OSIR.org.in (Free subscription) | 05/09/2008
COLUMBIA, Md.–(BUSINESS WIRE)–May 8, 2008 - Osiris Therapeutics, Inc. (NASDAQ:OSIR) today announced it has been given clearance by the U.S. Food and Drug Administration (FDA) to initiate an expanded access treatment program for Prochymal, making Source: www.pharmalive.com
Food and Drug Administration (Free subscription) | 05/09/2008
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
The Philadelphia Business Journal (Free subscription) | 05/09/2008
Adolor Corp. said Friday that the Food and Drug Administration will not issue an action letter regarding the company's Entereg gastrointestinal drug by Saturday, which had been the anticipated decision date. (ADLR)
ProudToBeCanadian Blog (Free subscription) | 05/09/2008
Who needs the Food and Drug Administration? New York Democrat Sen. Chuck Schumer and personal injury lawyers certainly don't—at least to the extent the agency gets in the way of their political grandstanding and a multi-million dollar payday, respectively. This column recently reported on the sad tale of the chemical bisphenol A (BPA)—that is, how junk science-fueled anti-chemical...
Red Orbit (Free subscription) | 05/09/2008
Adolor Corporation (Nasdaq:ADLR) announced today that the U.S. Food and Drug Administration (FDA) has communicated to the company that it will not be issuing an action letter on the NDA for Entereg® (alvimopan) for postoperative ileus by May 10, 2008, the scheduled PDUFA date.
