New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 25, 2013
06:57 EDTVNDAVanda reports successful completion of pre-NDA meeting with FDA on tasimelteon
Vanda Pharmaceuticals announced that the company held a pre-NDA meeting with the Division of Neurology Products of the FDA to discuss the regulatory path for filing a New Drug Application, or NDA, for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder. Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals. Currently there is no FDA approved treatment for Non-24. At the pre-NDA meeting, the FDA confirmed that the efficacy and safety data proposed by Vanda to be submitted in the tasimelteon NDA for Non-24 is adequate to support filing. The NDA supporting package that includes data from clinical pharmacology, pre-clinical pharmacology program, chemistry and manufacturing was also deemed adequate to support filing.
News For VNDA From The Last 14 Days
Check below for free stories on VNDA the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
September 15, 2014
15:12 EDTVNDAVanda management to meet with Piper Jaffray
Meeting to be held in New York on September 16 hosted by Piper Jaffray.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use