WASHINGTON – The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.The consumer group, Public Citizen, filed a petition with the Food and Drug ...Read More
Genzyme Corp. yesterday said US regulators are delaying approval of Lumizyme, its drug to treat the rare genetic disorder Pompe disease in adults, until the Cambridge biotechnology company solves persistent problems at its cell culture manufacturing plant in Allston. Genzyme officials ...Read More
The U.S. Food and Drug Administration is holding off on its review of Lumizyme, a treatment for the rare muscular disorder Pompe disease, until drug maker Genzyme Corp. resolves manufacturing problems at its Allston plant.
The Cambridge biotechnology firm said it ...Read More
Genzyme Corp. today said US regulators are delaying approval of Lumizyme, its drug to treat the rare genetic disorder Pompe disease in adults, until the Cambridge biotechnology company solves persistent problems at its cell-culture manufacturing plant in Allston. Genzyme officials said ...Read More
An experimental non-hormonal drug helped women increase their sexual desire and satisfaction and reduced the distress associated with lack of desire, researchers reported today. The clinical trial in 1,378 premenopausal women will provide the drug's manufacturer, Boehringer-Ingelheim Pharmaceuticals of Germany, ...Read More
Human Genome Sciences said Monday that approval of its experimental anthrax drug hit a delay as regulators asked the firm for more information about the treatment. The Food and Drug Administration wrote in a letter to the Rockville company that it ...Read More
* FDA rejects Genzyme's Pompe disease drug * Cites deficiencies at manufacturing plant in Boston * Shares up as shipping still on track (Updates with details from company conference call) BOSTON (Reuters) - Genzyme Corp ( GENZ - news - people ), which isstruggling ...Read More
(Updates throughout with company comments, analyst reaction and fresh stock price.) NEW YORK (Dow Jones)--The U.S. Food and Drug Administration notified Genzyme Corp. (GENZ) of new deficiencies at its primary manufacturing plant in Massachusetts, delaying the approval of Pompe disease treatment ...Read More
Human Genome Sciences Inc. said federal regulators still need more information before they can approve the Rockville company’s anthrax treatment, delivering a blow in what’s otherwise been a good month for the company. The Food and Drug Administration still had questions ...Read More
* Gets complete response letter for raxibacumab BLA * Says FDA requested additional information * Says plans to address the current questions * Shares flat (Adds analyst comments, background; updates stock movement) BANGALORE, Nov 16 (Reuters) - Human Genome Sciences Inc(HGSI.O) said the U.S. ...Read More
CAMBRIDGE, Mass.—Genzyme Corp. said Monday the Food and Drug Administration will not approve the potential Pompe disease treatment Lumizyme until the company fixes manufacturing problems at the company's Boston-area facility. Pompe disease is a genetic disorder that interferes with muscle development ...Read More
CAMBRIDGE, Mass. (AP) - Genzyme Corp. said Monday the Food and Drug Administration will not approve the potential Pompe disease treatment Lumizyme until the company fixes manufacturing problems at the company's Boston-area facility. Pompe disease is a genetic disorder that interferes ...Read More
* Gets approval to market generic Ultram ER * Says to begin shipping the drug immediately * Gets 180days marketing exclusivity * Shares up 4 pct in pre-mkt trade Nov 16 (Reuters) - Generic drugmaker Par PharmaceuticalCos Inc (PRX.N) said it received regulatory ...Read More
NEWPORT, Ky., Nov. 16 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S. Food and ...Read More
In October, a Food and Drug Administration official announced that, starting in 2011, the FDA would no longer allow fresh, live oysters from the Gulf of Mexico to be sold between the months of May and October. This ban would ...Read More
Reporting from Los Angeles and Washington - Alcoholic energy drinks, marketed under provocative names such as Evil Eye, Max Fury and Slingshot Party Gel, have quickly gained a foothold among younger drinkers. Now the producers of those beverages have a new, ...Read More
Nov. 14 (Bloomberg) -- The Food and Drug Administrationthis week told about 30 makers of caffeinated alcoholic drinksit is investigating the safety and legality of their products. Companies including Diageo North America Inc.,Constellation Brands Inc. and United Brands Co. were told ...Read More
WASHINGTON - Federal health officials have approved a new drug as the first non-hormonal treatment for heavy menstrual bleeding. The Food and Drug Administration says Lysteda tablets reduce bleeding by acting on a protein that helps blood clot. The drug is ...Read More
Washington - Facing fierce resistance, the Obama administration on Friday backed off a plan to ban sales of raw oysters from the Gulf of Mexico during warm-weather months.The Food and Drug Administration said it would put the proposal on hold ...Read More
U.S. health regulators requested information from nearly 30 makers of caffeinated alcoholic beverages on why they believe their products are safe. Among the companies targeted were Constellation Brands Inc., which makes the drink Wide Eye, and the North American unit of ...Read More
Federal health officials have approved a new drug as the first non-hormonal treatment for heavy menstrual bleeding. The Food and Drug Administration says Lysteda tablets reduce bleeding by acting on a protein that helps blood clot. The drug is made by ...Read More
