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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 22, 2026 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as ADHEROZA (DIN 02550989) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database —… | DIN02550989 | approvedsource: Marketed | health-canada-dpd |
| Sep 18, 2026 | Abemaciclib | FDA US | cancer not stated in this record | Efficacy supplement 2026-09-18 (see label) | SUPPLNDA208716 | approved | openfda |
| Sep 14, 2026 | Ropeginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as BESREMI (DIN 02569728) under ATC L03AB15 ROPEGINTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02569728 | approvedsource: Marketed | health-canada-dpd |
| 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 31, 2026 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562502) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product… | DIN02562502 |
| 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 | Lurbinectedin | EMA EU | Lung Small Cell Carcinoma | Zepzelca, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell… |
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 |
| Aug 12, 2026 | Pimicotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PIMJETMI (DIN 02569035) under ATC L01X OTHER ANTINEOPLASTIC AGENTS. Indications are not published in the Drug Product… | DIN02569035 | approvedsource: Marketed | health-canada-dpd |
| Aug 4, 2026 | Selpercatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as RETEVMO (DIN 02565676) under ATC L01EX22 SELPERCATINIB. Indications are not published in the Drug Product Database —… | DIN02565676 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Jul 31, 2026 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562499) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product… | DIN02562499 | approvedsource: Marketed | health-canada-dpd |
| Jul 31, 2026 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562480) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product… | DIN02562480 | approvedsource: Marketed | health-canada-dpd |
| Jul 31, 2026 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562472) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product… | DIN02562472 | approvedsource: Marketed | health-canada-dpd |
| Jul 31, 2026 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562464) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product… | DIN02562464 | approvedsource: Marketed | health-canada-dpd |
| Jul 24, 2026 | Amivantamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as RYBREVANT SC (DIN 02569175) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database… | DIN02569175 | approvedsource: Marketed | health-canada-dpd |
| Jul 24, 2026 | Amivantamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as RYBREVANT SC (DIN 02569167) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database… | DIN02569167 | approvedsource: Marketed | health-canada-dpd |
| Jul 24, 2026 | Amivantamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as RYBREVANT SC (DIN 02569159) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database… | DIN02569159 | approvedsource: Marketed | health-canada-dpd |
| Jul 24, 2026 | Amivantamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as RYBREVANT SC (DIN 02569140) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database… | DIN02569140 | approvedsource: Marketed | health-canada-dpd |
| Jul 24, 2026 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYCLOPHOSPHAMIDE FOR INJECTION USP (DIN 02560224) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published… | DIN02560224 | approvedsource: Marketed | health-canada-dpd |
| Jul 24, 2026 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYCLOPHOSPHAMIDE FOR INJECTION USP (DIN 02560216) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published… | DIN02560216 | approvedsource: Marketed | health-canada-dpd |
| Jul 24, 2026 | Enzalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2026-07-24 (see label) | SUPPLNDA213674 | 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 20, 2026 | Camizestrant | EMA EU | cancer not stated in this record | Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment… | centralisedEMEA/H/C/006494 | approved | ema |
| Jul 15, 2026 | Alpelisib | EMA EU | cancer not stated in this record | Treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related… | centralisedEMEA/H/C/006539 | approved | ema |
| 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 19, 2026 | Palbociclib | EMA EU | Malignant Breast Neoplasm | Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2… | centralisedEMEA/H/C/006624 | approved | ema |
| Jun 16, 2026 | Mosunetuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as LUNSUMIO SC (DIN 02567377) under ATC L01FX25 MOSUNETUZUMAB. Indications are not published in the Drug Product… | DIN02567377 | approvedsource: Marketed | health-canada-dpd |
| Jun 16, 2026 | Mosunetuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as LUNSUMIO SC (DIN 02567369) under ATC L01FX25 MOSUNETUZUMAB. Indications are not published in the Drug Product… | DIN02567369 | approvedsource: Marketed | health-canada-dpd |
| 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 |
| Jun 3, 2026 | Zolbetuximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as VYLOY (DIN 02563916) under ATC L01FX31 ZOLBETUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02563916 | approvedsource: Marketed | health-canada-dpd |
| Jun 2, 2026 | Daunorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as DAUNORUBICIN INJECTABLE SOLUTION (DIN 02501481) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the… | DIN02501481 | approvedsource: Marketed | health-canada-dpd |
| centralisedEMEA/H/C/006673 |
| approved |
| ema |
| May 29, 2026 | Tarlatamab | EMA EU | Lung Small Cell Carcinoma | Imdylltra is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who… | centralisedEMEA/H/C/006451 | approved | ema |