Coherus BioSciences' (CHRS) Neulasta BLA Accepted by U.S. FDA
- AT&T (T) Agrees to Acquire Time Warner (TWX) for More than $80 Billion - WSJ
- Top 10 News for 10/17 - 10/21: Merger Rumors Abound; CEOs Depart; Tesla Kicks Autopilot Up A Notch
- Wall Street ends little changed; Microsoft hits record
- AT&T (T) in Advanced Talks to Acquire Time Warner (TWX) - DJ
- Rockwell Automation (ROK) Said to Attract Takeover Interest from Schneider Electric - Source
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
- Baird Starts Coherus Biosciences (CHRS) at Outperform
- Pfizer (PFE), Astellas Announce FDA Approval of Updated XTANDI Label for Adv. Prostate Cancer
- Coherus BioSciences Announces New Employment Inducement Grants
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!