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Latest FDA Fast Track Development Program Stories

2014-08-27 08:28:22

THOUSAND OAKS, Calif., Aug. 27, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the I(f) current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.(1) Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular...

2014-08-04 08:28:32

Significant company milestones include completion of the Phase 2 PUNCH(TM) CD clinical trial and FDA designation of RBX2660 as Orphan Drug and Fast Track ROSEVILLE, Minn., Aug 4, 2014 /PRNewswire/ -- Rebiotix Inc. announced this morning that it has raised a total of $25 million in Series B Funding. The total funds raised since inception by the clinical-stage biotechnology company founded in 2011 is $30 million. Rebiotix will use the additional funds to support pivotal clinical...

2014-04-21 16:25:21

Urges FDA to Move Quickly with Final Approval of Eteplirsen WASHINGTON, April 21, 2014 /PRNewswire/ -- The Race to Yes campaign today lauded drug maker Sarepta on its plans to move forward immediately to seek FDA approval of the first drug to successfully treat Duchenne muscular dystrophy, the world's leading genetic killer of children. http://photos.prnewswire.com/prnvar/20140311/MM81272LOGO "We have been waiting for this for a long time," said Tracy Seckler, whose son, Charley,...

2014-03-18 23:26:23

Launch of ADDPLAN® 6.1 to Expedite and Improve Decision-Making in Clinical Trials Reston, Virginia (PRWEB) March 18, 2014 Aptiv Solutions, a global biopharmaceutical and medical device development services company leading the design and implementation of innovative approaches that improve data quality, efficiency, and productivity of product development, today announced the release of ADDPLAN® 6.1, the first statistical software to enable the use of surrogate endpoints to...

2014-03-17 00:23:45

EPI-743 in two phase 2 development studies for Friedreich's ataxia MOUNTAIN VIEW, Calif., March 17, 2014 /PRNewswire/ -- Edison Pharmaceuticals today announced that the United States Food and Drug Administration granted Fast Track designation to EPI-743, the company's lead drug, for the treatment of Friedreich's ataxia. EPI-743 is being developed for pediatric and adult mitochondrial disease, including Friedreich's ataxia. EPI-743 has successfully completed phase 1 and multiple...

2014-03-04 12:27:01

Parents Pushing FDA for Accelerated Approval of Safe and Effective Drug WASHINGTON, March 4, 2014 /PRNewswire-iReach/ -- After calling on the FDA directly to approve a breakthrough therapy for Duchenne Muscular Dystrophy, and appealing to Congress on behalf of the thousands of children facing this fatal genetic disease, concerned families have launched a national campaign and petition drive called "The Race to Yes" at TheRacetoYes.org to underscore the urgent need for accelerated...

2014-02-10 20:21:08

Call on FDA for Accelerated Approval of Promising Duchenne Muscular Dystrophy Treatment WASHINGTON, Feb. 10, 2014 /PRNewswire-iReach/ -- Health staffers from over 80 Congressional offices together with agency and industry officials jammed a briefing room last Friday to hear mothers, clinicians and leading researchers call on the FDA to accept and promptly review a new drug application for eteplirsen, a promising new treatment for Duchenne Muscular Dystrophy that could save thousands...


Word of the Day
monteith
  • A large punch-bowl of the eighteenth century, usually of silver and with a movable rim, and decorated with flutings and a scalloped edge. It was also used for cooling and carrying wine-glasses.
  • A kind of cotton handkerchief having white spots on a colored ground, the spots being produced by a chemical which discharges the color.
This word is possibly named after Monteith (Monteigh), 'an eccentric 17th-century Scotsman who wore a cloak scalloped at the hem.'
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