Treatment Watch
2715 eventsUpdated todayFDA drug approvals, PDUFA decisions, orphan designations, and breakthrough therapy designations for rare diseases — sourced daily from FDA.gov.
All eventsFDA approval (620)PDUFA date (0)Orphan designation (0)Breakthrough therapy (0)Complete response letter (0)Upcoming only·Year:All2026202520242023202220212020201920182017
103 events · 2019
Dec 27
2019
label expansion
Dec 20
2019
FDA approvalOrphan drug
Rare genetic ophthalmic disorder with cortical involvement· Dutch Ophthalmic Research Center International BV
Dec 17
2019
label expansion
· Alembic Pharmaceuticals Limited· ANDA201168
Dec 13
2019
label expansion
Dec 12
2019
label expansion
Dec 9
2019
Dec 6
2019
label expansion
Dec 6
2019
label expansion
Dec 5
2019
label expansion
Nov 20
2019
Nov 7
2019
Nov 4
2019
Nov 1
2019
label expansion
Nov 1
2019
label expansion
Oct 22
2019
Oct 9
2019
label expansion
Oct 8
2019
Oct 6
2019
label expansion
Oct 6
2019
label expansion
Oct 3
2019
FDA approvalOrphan drug
Sep 23
2019
Sep 12
2019
label expansion
Sep 12
2019
Sep 12
2019
label expansion
Sep 12
2019
label expansion
Sep 12
2019
label expansion
Sep 12
2019
label expansion
Sep 6
2019
FDA approvalOrphan drug
Aug 28
2019
FDA approvalOrphan drug
Adenovirus infection in immunocompromised patients· Gilead Sciences, Inc.
Aug 15
2019
Aug 14
2019
label expansion
Aug 14
2019
Aug 14
2019
FDA approvalOrphan drug
Primary genito-urinary tuberculosis· Global Alliance for TB Drug Development
Aug 9
2019
FDA approval
· Unichem Pharmaceuticals (USA), Inc.· ANDA211825
Aug 2
2019
Jul 31
2019
label expansion
Jul 31
2019
label expansion
Jul 16
2019
label expansion
Jul 16
2019
label expansion
Jun 28
2019
FDA approvalOrphan drug
Homocystinuria due to cystathionine beta-synthase deficiency· Mission Pharmacal Company
Jun 26
2019
label expansion
Jun 24
2019
label expansion
· Macleods Pharmaceuticals Limited· ANDA202289
Jun 21
2019
label expansion
May 31
2019
label expansion
May 31
2019
label expansion
May 30
2019
May 30
2019
label expansion
May 30
2019
label expansion
May 30
2019
label expansion
May 28
2019
FDA approvalOrphan drug
May 24
2019
label expansion
May 17
2019
FDA approvalOrphan drug
May 16
2019
label expansion
May 2
2019
label expansion
May 2
2019
label expansion
Apr 29
2019
label expansion
Apr 26
2019
label expansion
Apr 26
2019
FDA approval
Apr 26
2019
FDA approval
Apr 26
2019
FDA approval
Apr 10
2019
FDA approval
Apr 9
2019
Mar 11
2019
label expansion
Feb 22
2019
label expansion
Feb 22
2019
FDA approvalOrphan drug
Adenocarcinoma of the oesophagus and oesophagogastric junction· Taiho Oncology, Inc.
Feb 21
2019
label expansion
Feb 6
2019
FDA approvalOrphan drug
Jan 25
2019
label expansion
· Medline Industries, LP· NDA019422
Jan 23
2019
label expansion
Jan 14
2019
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.