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Regulatory
Every record is one authority's decision for one application or DIN, shown with its jurisdiction, date, indication text as published and status. A molecule approved in one jurisdiction for one indication is not 'approved' in general.
RegulatoryDevelopment pipeline →Methodology
Coverage
Counts of records, not of drugs approved: one application can carry several dated records (original approval, efficacy supplements, one row per DIN in Canada).
Approval records
4,340
Distinct drugs
372
Records naming a cancer
982
Dated in the last 12 months
182
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |
|---|---|---|---|---|---|---|---|
| FDA | US | 2,343 | 304 | 2,343 | 0 | 115 | Sep 18, 2026 |
| Health Canada | CA | 1,538 | 273 | 979 | 559 | 49 | Sep 22, 2026 |
| EMA | EU | 459 | 245 | 385 | 74 | 18 | Jul 20, 2026 |
Data updated 18 hours agoSource updated unknown3 authority · jurisdiction pairs ingested
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Latest approval date first; records without a date are listed last. Filters combine.
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 18, 2026 | Abemaciclib | FDA US | cancer not stated in this record | Efficacy supplement 2026-09-18 (see label) | SUPPLNDA208716 | approved | openfda |
| Sep 9, 2026 | Aminolevulinic Acid | FDA US | cancer not stated in this record | Efficacy supplement 2026-09-09 (see label) | SUPPLNDA208081 | approved | openfda |
| Sep 9, 2026 | Sevabertinib | FDA US | cancer not stated in this record | Efficacy supplement 2026-09-09 (see label) | SUPPLNDA219972 | approved | openfda |
| Sep 4, 2026 | Camizestrant | FDA US | Malignant Breast Neoplasm | in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor… | ORIGNDA220359 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 28, 2026 | Ropeginterferon Alfa-2b | FDA US | cancer not stated in this record | Efficacy supplement 2026-08-28 (see label) | SUPPLBLA761166 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 24, 2026 | Enzalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2026-07-24 (see label) | SUPPLNDA213674 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 29, 2026 | Roflumilast | FDA US | cancer not stated in this record | Efficacy supplement 2026-06-29 (see label) | SUPPLNDA215985 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 29, 2026 | Nilotinib | FDA US | cancer not stated in this record | Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. | ORIGNDA217379 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 27, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-27 (see label) | SUPPLBLA761139 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 30, 2026 | Retifanlimab | FDA US | cancer not stated in this record | Efficacy supplement 2026-03-30 (see label) | SUPPLBLA761334 | approved | openfda |
A record is one authority's decision for one application/DIN; the same molecule appears once per jurisdiction and indication. Health Canada DPD does not publish indications — its records state the brand, DIN and ATC class only, and a cancelled or dormant DIN is the status of one product, not of the molecule. FDA cancer mappings come from label text and are flagged probabilistic on the drug page.
| Aug 25, 2026 | Zanidatamab | FDA US | cancer not stated in this record | Efficacy supplement 2026-08-25 (see label) | SUPPLBLA761416 | approved | openfda |
| Aug 25, 2026 | Tislelizumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-08-25 (see label) | SUPPLBLA761232 | approved | openfda |
| Jul 24, 2026 | Enzalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2026-07-24 (see label) | SUPPLNDA203415 | approved | openfda |
| Jul 14, 2026 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2026-07-14 (see label) | SUPPLNDA213246 | approved | openfda |
| Jul 14, 2026 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2026-07-14 (see label) | SUPPLNDA218160 | approved | openfda |
| Jul 13, 2026 | Abemaciclib | FDA US | cancer not stated in this record | Efficacy supplement 2026-07-13 (see label) | SUPPLNDA208716 | approved | openfda |
| Jul 10, 2026 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-07-10 (see label) | SUPPLBLA125514 | approved | openfda |
| Jul 10, 2026 | Enfortumab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2026-07-10 (see label) | SUPPLBLA761137 | approved | openfda |
| Jul 1, 2026 | Ribociclib | FDA US | cancer not stated in this record | Efficacy supplement 2026-07-01 (see label) | SUPPLNDA209092 | approved | openfda |
| Jun 26, 2026 | Vimseltinib | FDA US | cancer not stated in this record | Efficacy supplement 2026-06-26 (see label) | SUPPLNDA219304 | approved | openfda |
| Jun 24, 2026 | Sacituzumab Govitecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-06-24 (see label) | SUPPLBLA761115 | approved | openfda |
| Jun 24, 2026 | Sacituzumab Govitecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-06-24 (see label) | SUPPLBLA761115 | approved | openfda |
| Jun 24, 2026 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-06-24 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 24, 2026 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2026-06-24 (see label) | SUPPLNDA212436 | approved | openfda |
| Jun 24, 2026 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2026-06-24 (see label) | SUPPLNDA207103 | approved | openfda |
| Jun 12, 2026 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-06-12 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 12, 2026 | Capivasertib | FDA US | cancer not stated in this record | Efficacy supplement 2026-06-12 (see label) | SUPPLNDA218197 | approved | openfda |
| Jun 12, 2026 | Belzutifan | FDA US | cancer not stated in this record | Efficacy supplement 2026-06-12 (see label) | SUPPLNDA215383 | approved | openfda |
| Jun 11, 2026 | Alectinib | FDA US | cancer not stated in this record | Efficacy supplement 2026-06-11 (see label) | SUPPLNDA208434 | approved | openfda |
| openfda |
| May 29, 2026 | Nilotinib | FDA US | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included… | ORIGNDA217379 | approved | openfda |
| May 28, 2026 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-28 (see label) | SUPPLBLA761069 | approved | openfda |
| May 22, 2026 | Datopotamab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-22 (see label) | SUPPLBLA761394 | approved | openfda |
| May 20, 2026 | Venetoclax | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-20 (see label) | SUPPLNDA208573 | approved | openfda |
| May 18, 2026 | Retifanlimab | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-18 (see label) | SUPPLBLA761334 | approved | openfda |
| May 15, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-15 (see label) | SUPPLBLA761139 | approved | openfda |
| May 15, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-15 (see label) | SUPPLBLA761139 | approved | openfda |
| May 15, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-15 (see label) | SUPPLBLA761139 | approved | openfda |
| May 15, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-15 (see label) | SUPPLBLA761139 | approved | openfda |
| May 15, 2026 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-15 (see label) | SUPPLBLA761034 | approved | openfda |
| May 1, 2026 | Trabectedin | FDA US | cancer not stated in this record | EVDI is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior… | ORIGNDA220837 | approved | openfda |
| May 1, 2026 | Ruxolitinib | FDA US | cancer not stated in this record | intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential… | ORIGNDA217180 | approved | openfda |
| May 1, 2026 | Ruxolitinib | FDA US | Polycythemia Vera | polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. | ORIGNDA217180 | approved | openfda |
| Apr 27, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-27 (see label) | SUPPLBLA761139 | approved | openfda |
| Apr 23, 2026 | Selinexor | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-23 (see label) | SUPPLNDA212306 | approved | openfda |
| Apr 23, 2026 | Pertuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-23 (see label) | SUPPLBLA125409 | approved | openfda |
| Apr 15, 2026 | Inavolisib | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-15 (see label) | SUPPLNDA219249 | approved | openfda |
| Apr 9, 2026 | Azacitidine | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-09 (see label) | SUPPLNDA214120 | approved | openfda |
| Apr 2, 2026 | Aflibercept | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-02 (see label) | SUPPLBLA761355 | approved | openfda |
| Mar 27, 2026 | Epcoritamab | FDA US | cancer not stated in this record | Efficacy supplement 2026-03-27 (see label) | SUPPLBLA761324 | approved | openfda |
| Mar 20, 2026 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-03-20 (see label) | SUPPLBLA125554 | approved | openfda |