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
Sign up for a free trial to see the rest of the stories you've been missing.
July 2, 2015
09:07 EDTVNDAVanda has new Hetlioz patent listed in FDA Orange Book
Vanda announced that a Hetlioz patent is now listed in the FDA publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The 'patent was issued by the USPTO on June 23rd and expires in January 2033.
07:27 EDTVNDAPublic Citizen calls on FDA to correct labeling of Vanda's Hetlioz drug
Subscribe for More Information
June 24, 2015
10:03 EDTVNDAHigh option volume stocks: VNDA SN ADHD UNIS
June 23, 2015
19:03 EDTVNDAOn The Fly: After Hours Movers
UP AFTER PROVIDING GUIDANCE: MeetMe (MEET), up 18.8%. ALSO HIGHER: Nektar Therapeutics (NKTR), up 4.3% after being added to S&P 600... Quidel (QDEL), up 5% after receiving FDA clearance for new Solana molecular system and assay... Vanda Pharmaceuticals (VNDA), up 4.6% after announcing positive results from REPRIEVE study... Netflix (NFLX), up 3.4% after announcing seven-for-one stock split. LOWER: Alcobra (ADHD), down 2.5% after announcing that it will host a conference call and simultaneous webcast presentation to present results from the Phase II clinical trial of MDX... Sysco (SYY), down 2.6% after bid for U.S. foods blocked was blocked by a federal judge... Boeing (BA), down marginally after announcing CEO transition.
16:32 EDTVNDAVanda announces positive results from REPRIEVE study
Subscribe for More Information
07:36 EDTVNDAJMP Securities to hold a conference
Subscribe for More Information

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