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Latest US Food and Drug Administration Stories

2014-09-18 08:29:25

Key evaluation to inform the US Food and Drug Administration regulatory submission SYDNEY, Sept. 18, 2014 /PRNewswire/ -- Australian biomarker discovery company Minomic International Ltd will today launch an important US trial of its MiStat(TM) prostate cancer screening test, planning to achieve US Food and Drug Administration (FDA) regulatory approval upon completion. Minomic's proprietary MiStat(TM) technology is a screening assay capable of identifying the presence of a...

2014-09-17 08:28:52

Pivotal Phase 3 Clinical Trial Targeted to Begin in First Half of 2015 PRINCETON, N.J., Sept. 17, 2014 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that agreement has been reached with the US Food and Drug Administration (FDA) on the design of a pivotal, Phase 3 clinical trial evaluating its...

2014-09-05 08:23:11

Newly Acquired SGX301 Orphan Drug Candidate Being Evaluated for Treatment of Cutaneous T-Cell Lymphoma PRINCETON, N.J., Sept. 5, 2014 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today the acquisition of a novel orphan drug candidate, known as SGX301 (synthetic hypericin). SGX301 is poised to enter...

2014-07-31 12:23:57

LISBON, Portugal, July 31, 2014 /PRNewswire/ -- Hovione today announced that its API plant in Cork, Ireland has successfully passed a pre-approval inspection by the US Food and Drug Administration (FDA). The inspection, carried out by the FDA Consumer Safety Officer, Ms. Britanny Terhar, lasted 5 days as initially planned, started on 21st July and concluded on the 25th. The inspection confirmed the site to be compliant with the principles and guidelines of Good...

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...


Word of the Day
humgruffin
  • A terrible or repulsive person.
Regarding the etymology of 'humgruffin,' the OED says (rather unhelpfully) that it's a 'made-up word.' We might guess that 'hum' comes from 'humbug' or possibly 'hum' meaning 'a disagreeable smell,' while 'gruffin' could be a combination of 'gruff' and 'griffin.'