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
- 1939 Views
-
Last post by frodo
-
- 0 Replies
- 1307 Views
-
Last post by NHE
-
- 0 Replies
- 1695 Views
-
Last post by frodo
-
- 0 Replies
- 1245 Views
-
Last post by frodo
-
- 1 Replies
- 1787 Views
-
Last post by frodo
-
- 0 Replies
- 2099 Views
-
Last post by NHE
-
- 0 Replies
- 2494 Views
-
Last post by NHE
-
- 0 Replies
- 1073 Views
-
Last post by frodo
-
- 1 Replies
- 1507 Views
-
Last post by NHE