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Latest US Food and Drug Administration Stories

2014-07-18 08:24:03

DUBLIN, July 18, 2014 /PRNewswire/ -- NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION (IN WHOLE OR IN PART) IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION. Increases Non GAAP diluted earnings per ADS guidance to low-to-mid thirty percent growth in 2014. Shire (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the three months to June 30, 2014....

2014-07-16 08:29:36

FREDERICK, Md., July 16, 2014 /PRNewswire/ -- ImQuest Pharmaceuticals was recently notified by the US Food and Drug Administration of the approval of its Investigational New Drug (IND) application to study the safety in Phase 1 clinical trials of its vaginal gel containing the nonnucleoside reverse transcriptase HIV Inhibitor IQP-0528. Preclinical studies have shown that IQP-0528 is highly effective against virus strains found throughout the world, prevents HIV transmission in...

2014-06-16 08:28:43

Cell-culture technology is a modern alternative to manufacture influenza vaccines without chicken eggs, with potential to rapidly respond to a pandemic[1] BASEL, Switzerland, June 16, 2014 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) licensed its manufacturing facility in Holly Springs, N.C. for the production of cell-culture influenza vaccines. This is the first US facility of its kind and is now approved for commercial production. The site will...

2014-05-01 08:36:55

WASHINGTON, May 1, 2014 /PRNewswire/ -- The US Drug Watchdog is now suggesting recipients of an all metal hip implant check out the UK's University of Newcastle's web site about updated news related to all metal hip implant failures, because they believe this resource is much better than anything currently being offered by US Food and Drug Administration. The Watchdog is calling the US FDA a no show, to what they are calling the, "US metal on metal hip implant disaster."...

2014-04-24 12:31:30

Legacy® Presses for Consistency in Restrictions on Combusted and Non-combusted Products, Especially as They Relate to Candy Flavorings and Advertising Appealing to Youth WASHINGTON, April 24, 2014 /PRNewswire-USNewswire/ -- Today, the Food and Drug Administration (FDA) took a critically important step - although long overdue and still too limited - to improve the health of our nation by commencing the formal rulemaking process to bring additional tobacco products under its...

2014-04-01 16:25:15

- Timely collaborations underscore ViiV Healthcare's commitment to increase access to life-saving HIV medicines for children and adults in the developing world LONDON, April 1, 2014 /PRNewswire/ -- ViiV Healthcare today announced new collaborations with the goal of increasing access to its HIV medicine, dolutegravir (marketed under the name Tivicay®), just two months after its approval by the European Medicines Agency (EMA) and eight months after approval by the US Food and Drug...

2014-01-11 23:00:36

Today marked the official inauguration of its expanded state-of-the-art laboratory and administrative facility in Shanghai, China. Shanghai (PRWEB) January 11, 2014 The U.S. Pharmacopeial Convention (USP), a nonprofit global health organization that creates and promotes quality standards for medicines, herbal medicines/dietary supplements and food ingredients, today marked the official inauguration of its expanded state-of-the-art laboratory and administrative facility in Shanghai, China....

2014-01-09 08:28:50

EMERYVILLE, Calif., Jan. 9, 2014 /PRNewswire/ -- Adamas Pharmaceuticals, Inc. announced today that it has received $40 million in milestone payments from Forest Laboratories Holdings Limited (NYSE: FRX) for MDX-8704. MDX-8704 is a fixed dosed combination (FDC) of Namenda XR(®) (memantine HCl extended release capsules) and donepezil HCl being developed as a once daily therapy for the treatment of moderate-to-severe dementia of the Alzheimer's type in the United States. The...


Word of the Day
glogg
  • Scandinavian punch made of claret and aquavit with spices and raisins and orange peel and sugar.
This word comes from the Swedish 'glogg,' which is an alteration of 'glodgat,' mulled (wine).
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