Coherus BioSciences' (CHRS) Neulasta BLA Accepted by U.S. FDA
- Wall Street dips as telecoms slump; AmEx surges
- Microsoft (MSFT) Tops Q1 EPS by 8c
- AMD (AMD) Posts Q3 Operating EPS of 3c; Sees Q4 Revenue Down Sequentially
- AT&T (T) Said to Discuss Idea of Takeover in Time Warner (TWX) Meetings
- After-Hours Stock Movers 10/20: (CERC) (ALKS) (PFPT) (MSFT) Higher; (SKX) (RRGB) (AMD) Lower (more...)
Get access to the best calls on Wall Street with StreetInsider.com's Ratings Insider Elite. Get your Free Trial here.
Coherus BioSciences, Inc. (Nasdaq: CHRS) announced that the U.S. FDA has accepted the filing of 351(k) Biologics License Application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate.
The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta. The biosimilar user fee act (BSUFA) action date is June 9, 2017.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Alkermes plc (ALKS) Announces Third ALKS 5461 Phase 3 Met Primary Endpoint in MDD
- Alkermes' (ALKS) FORWARD-5 Pivotal Phase 3 Study of ALKS 5461 for Major Depressive Disorder Mets Primary Endpoint
- ARIAD Pharma (ARIA) Acknowledges Receipt of Congressional Letter; Issues Commentary
Create E-mail Alert Related CategoriesCorporate News, FDA
Sign 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!