Treatment Watch
2591 eventsUpdated todayFDA drug approvals, PDUFA decisions, orphan designations, and breakthrough therapy designations for rare diseases — sourced daily from FDA.gov.
All eventsFDA approval (873)PDUFA date (0)Orphan designation (0)Breakthrough therapy (0)Complete response letter (0)Upcoming only·Year:All2015201420132012201120102009200820072006
17 events · FDA approval · 2013
Dec 13
2013
FDA approvalOrphan drug
Nov 22
2013
FDA approvalOrphan drug
Adenocarcinoma of the gallbladder and extrahepatic biliary tract· Bayer HealthCare Pharmaceuticals, Inc.
Nov 1
2013
FDA approvalOrphan drug
T-cell prolymphocytic leukemia· Genentech Inc., a member of the Roche Group
Oct 8
2013
Sep 6
2013
FDA approvalOrphan drug
Familial atypical multiple mole melanoma syndrome· Abraxis BioScience, LLC
May 29
2013
FDA approval
May 29
2013
FDA approval
May 10
2013
FDA approvalOrphan drug
Acquired aneurysmal subarachnoid hemorrhage· Arbor Pharmaceuticals, Inc.
Apr 29
2013
FDA approvalOrphan drug
Mar 28
2013
FDA approval
· Neos Therapeutics, LP· NDA022556
Feb 28
2013
FDA approval
Not medical advice — always consult your healthcare provider before making treatment decisions.
Data sourced from FDA.gov and openFDA, updated daily. Dates are subject to change. Always verify with FDA.gov for official decisions.