Amgen's Prolia gets complete response from US FDA for PMO
19 October 2009
Asher Mullard
The
US FDA has hit
Amgen with a complete response letter for its big hope, the bone drug Prolia (denosumab). While the agency has not requested more clinical studies for the postmenopausal osteoporosis (PMO) treatment indication, further trials are needed if it is to be approved as a preventative...
Please Login to read the full article.
19 October 2009
Asher Mullard
Please Login to read the full article.
RELATED CONTENT
NEWS
- Iron chelator, prostate cancer conundrum on deck for ODAC
- With questions raised on prostate cancer benefit, Amgen's Xgeva may face tough ODAC
- Amgen fails to convince ODAC of Xgeva's benefit in prostate cancer
- US Capitol Capsule: Supreme Court takes another stab at refining US patent law
COMMENT
Other Informa Comment
EVENTS
28 February 2012
Pestana Chelsea Bridge Hotel London
04 March 2012
The Marriott World Center, Orlando, Florida
26 March 2012
Copenhagen, Denmark
JOB OF THE WEEK
Promote your vacancy here
