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Latest FDA Fast Track Development Program Stories

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
attercop
  • A spider.
  • Figuratively, a peevish, testy, ill-natured person.
'Attercop' comes from the Old English 'atorcoppe,' where 'atter' means 'poison, venom' and‎ 'cop' means 'spider.' 'Coppa' is a derivative of 'cop,' top, summit, round head, or 'copp,' cup, vessel, which refers to 'the supposed venomous properties of spiders,' says the OED. 'Copp' is still found in the word 'cobweb.'
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