US FDA accepts MS drug Lemtrada resubmission for review
US FDA accepts MS drug Lemtrada resubmission for review
The US Food and Drug Administration (FDA) has accepted for review the Genzyme's resubmission of supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter...... Read More - http://www.ms-uk.org/lemtrada
MS-UK - http://www.ms-uk.org/
-
- Similar Topics
- Replies
- Views
- Last post
-
- 0 Replies
- 1813 Views
-
Last post by frodo
-
- 0 Replies
- 1161 Views
-
Last post by NHE
-
- 0 Replies
- 1624 Views
-
Last post by frodo
-
- 0 Replies
- 1146 Views
-
Last post by frodo
-
- 1 Replies
- 1568 Views
-
Last post by frodo
-
- 0 Replies
- 1940 Views
-
Last post by NHE
-
- 0 Replies
- 2199 Views
-
Last post by NHE
-
- 0 Replies
- 991 Views
-
Last post by frodo
-
- 1 Replies
- 1301 Views
-
Last post by NHE