Biogen Idec (BIIB) Said FDA Extends PDUFA Date for BG-12 3 Months
Tweet
Share
E-mailGet Alerts BIIB Hot Sheet
Down)Join SI Premium – FREE
Biogen Idec (NASDAQ: BIIB) said the FDA has extended the initial PDUFA date for its review of the New Drug Application (NDA) for the marketing approval of BG-12 (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). The 3 month extension is a standard extension period.
The FDA has indicated that the extension of the PDUFA date is needed to allow additional time for review of the application. The agency has not asked for additional studies.
The FDA has indicated that the extension of the PDUFA date is needed to allow additional time for review of the application. The agency has not asked for additional studies.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Biogen (BIIB) PT Lowered to $300 at H.C. Wainwright
- Regeneron (REGN) and Mammoth Biosciences Collaborate over Next-Generation CRISPR-Based Gene Editing for Multiple Diseases
- VistaGen Therapeutics (VTGN) Reports Positive Results from Phase 2A Pilot Study of PH15
Create E-mail Alert Related Categories
FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
