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
91 events · 2014
Dec 29
2014
label expansion
Dec 19
2014
Dec 18
2014
label expansion
Dec 18
2014
label expansion
Dec 15
2014
Dec 13
2014
label expansion
Dec 12
2014
label expansion
Dec 12
2014
Dec 12
2014
label expansion
Dec 11
2014
Dec 10
2014
label expansion
Dec 10
2014
Dec 5
2014
label expansion
Dec 2
2014
Nov 25
2014
label expansion
Nov 10
2014
Nov 4
2014
label expansion
· Macleods Pharmaceuticals Limited· ANDA202289
Oct 23
2014
FDA approvalOrphan drug
Rare thrombotic disorder due to a coagulation factors defect· Takeda Development Center Americas, Inc.
Oct 21
2014
label expansion
Oct 21
2014
label expansion
Oct 15
2014
FDA approvalOrphan drug
Oct 15
2014
Sep 29
2014
label expansion
Sep 26
2014
label expansion
· Prasco Laboratories· NDA022580
Sep 26
2014
Sep 26
2014
label expansion
Aug 25
2014
label expansion
Aug 15
2014
Aug 15
2014
label expansion
Aug 13
2014
label expansion
Aug 12
2014
Aug 11
2014
label expansion
Aug 1
2014
label expansion
Jul 30
2014
Jul 29
2014
Jul 23
2014
label expansion
· Baxter Healthcare Corporation· NDA019734
Jul 22
2014
FDA approvalOrphan drug
Multiple pterygium-malignant hyperthermia syndrome· Eagle Pharmaceuticals, Inc.
Jul 3
2014
FDA approvalOrphan drug
Primary cutaneous peripheral T-cell lymphoma not otherwise specified· Acrotech Biopharma LLC
Jun 28
2014
Jun 13
2014
label expansion
Jun 13
2014
FDA approvalOrphan drug
Immunodeficiency with isotype or light chain deficiencies with normal number of B-cells· Cardinal Health 414, LLC
Jun 9
2014
May 30
2014
label expansion
May 20
2014
label expansion
Apr 30
2014
Apr 28
2014
FDA approvalOrphan drug
Acute myeloblastic leukemia with maturation· Nova Laboratories Limited
Apr 17
2014
label expansion
Apr 8
2014
label expansion
Apr 3
2014
label expansion
Apr 3
2014
label expansion
Mar 28
2014
label expansion
Mar 28
2014
FDA approvalOrphan drug
Multisystem inflammatory syndrome in children and adults· Bioverativ Therapeutics, Inc.
Mar 28
2014
label expansion
Mar 18
2014
label expansion
Mar 11
2014
FDA approval
Feb 24
2014
FDA approvalOrphan drug
AKT2-related familial partial lipodystrophy· Chiesi Farmaceutici S.p.A.
Feb 21
2014
label expansion
Feb 7
2014
Jan 29
2014
label expansion
Jan 29
2014
label expansion
Jan 9
2014
label expansion
Jan 8
2014
label expansion
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.