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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
4,342
Distinct drugs
373
Records naming a cancer
982
Dated in the last 12 months
177
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 42 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 2 days agoSource updated unknown3 authority · jurisdiction pairs ingested
Feed
Latest approval date first; records without a date are listed last. Filters combine.
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 23, 2019 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE INJECTION BP (DIN 02474891) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN02474891 | approvedsource: Marketed | health-canada-dpd |
| Apr 23, 2019 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE INJECTION BP (DIN 02474735) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN02474735 | approvedsource: Marketed | health-canada-dpd |
| Apr 22, 2019 | Lorlatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as LORBRENA (DIN 02485974) under ATC L01ED05 LORLATINIB. Indications are not published in the Drug Product Database —… | DIN02485974 | approvedsource: Marketed | health-canada-dpd |
| Apr 22, 2019 | Lorlatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as LORBRENA (DIN 02485966) under ATC L01ED05 LORLATINIB. Indications are not published in the Drug Product Database —… | DIN02485966 | approvedsource: Marketed | health-canada-dpd |
| Apr 19, 2019 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-04-19 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 18, 2019 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-04-18 (see label) | SUPPLBLA125554 | approved | openfda |
| Apr 12, 2019 | Erdafitinib | FDA US | Urothelial Carcinoma | BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible… | ORIGNDA212018 | approved | openfda |
| Apr 11, 2019 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-04-11 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 4, 2019 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2019-04-04 (see label) | SUPPLNDA207103 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 29, 2019 | Cladribine | FDA US | cancer not stated in this record | MAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 27, 2019 | Enasidenib | Health Canada CA | cancer not stated in this record | Marketed in Canada as IDHIFA (DIN 02485435) under ATC L01XM01 ENASIDENIB. Indications are not published in the Drug Product Database — see… | DIN02485435 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 30, 2019 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2019-01-30 (see label) | SUPPLNDA021462 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 28, 2018 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2018-12-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Dec 21, 2018 |
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.
| ORIGNDA022561 |
| approved |
| openfda |
| Mar 29, 2019 | Busulfan | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-BUSULFAN (DIN 02477343) under ATC L01AB01 BUSULFAN. Indications are not published in the Drug Product Database —… | DIN02477343 | approvedsource: Marketed | health-canada-dpd |
| Mar 25, 2019 | Bortezomib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BORTEZOMIB (DIN 02456176) under ATC L01XG01 BORTEZOMIB. Indications are not published in the Drug Product Database —… | DIN02456176 | approvedsource: Marketed | health-canada-dpd |
| Mar 18, 2019 | Ceritinib | FDA US | cancer not stated in this record | ZYKADIA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic… | ORIGNDA211225 | approved | openfda |
| Mar 18, 2019 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-03-18 (see label) | SUPPLBLA761034 | approved | openfda |
| Mar 11, 2019 | Fulvestrant | FDA US | cancer not stated in this record | Efficacy supplement 2019-03-11 (see label) | SUPPLNDA021344 | approved | openfda |
| Mar 8, 2019 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-03-08 (see label) | SUPPLBLA761034 | approved | openfda |
| Mar 7, 2019 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-03-07 (see label) | SUPPLBLA125554 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Jun 30, 2023 |
| health-canada-dpd |
| Feb 27, 2019 | Enasidenib | Health Canada CA | cancer not stated in this record | Marketed in Canada as IDHIFA (DIN 02485427) under ATC L01XM01 ENASIDENIB. Indications are not published in the Drug Product Database — see… | DIN02485427 | withdrawnsource: Cancelled Post Marketsince Jun 30, 2023 | health-canada-dpd |
| Feb 27, 2019 | Pegfilgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as LAPELGA (DIN 02474565) under ATC L03AA13 PEGFILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02474565 | approvedsource: Marketed | health-canada-dpd |
| Feb 15, 2019 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-02-15 (see label) | SUPPLBLA125514 | approved | openfda |
| Feb 14, 2019 | Bevacizumab | EMA EU | cancer not stated in this record | Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of… | centralisedEMEA/H/C/004697 | approved | ema |
| Feb 8, 2019 | Daratumumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-02-08 (see label) | SUPPLBLA761036 | approved | openfda |
| Feb 1, 2019 | Fulvestrant | Health Canada CA | cancer not stated in this record | Marketed in Canada as FULVESTRANT INJECTION (DIN 02483610) under ATC L02BA03 FULVESTRANT. Indications are not published in the Drug Product… | DIN02483610 | approvedsource: Marketed | health-canada-dpd |
| Jan 25, 2019 | Rituximab | FDA US | cancer not stated in this record | Efficacy supplement 2019-01-25 (see label) | SUPPLBLA103705 | approved | openfda |
| Jan 25, 2019 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-01-25 (see label) | SUPPLNDA205552 | approved | openfda |
| Jan 25, 2019 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-01-25 (see label) | SUPPLNDA210563 | approved | openfda |
| Jan 23, 2019 | Encorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2019-01-23 (see label) | SUPPLNDA210496 | approved | openfda |
| Jan 23, 2019 | Binimetinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-01-23 (see label) | SUPPLNDA210498 | approved | openfda |
| Jan 18, 2019 | Vismodegib | FDA US | cancer not stated in this record | Efficacy supplement 2019-01-18 (see label) | SUPPLNDA203388 | approved | openfda |
| Jan 18, 2019 | Trastuzumab | FDA US | cancer not stated in this record | Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product ( 1 , 2.2 ). | ORIGBLA761100 | approved | openfda |
| Jan 18, 2019 | Trastuzumab | FDA US | Gastroesophageal Junction Adenocarcinoma | The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. | ORIGBLA761100 | approved | openfda |
| Jan 18, 2019 | Trastuzumab | FDA US | Malignant Breast Neoplasm | The treatment of HER2-overexpressing breast cancer. | ORIGBLA761100 | approved | openfda |
| Jan 15, 2019 | Pralatrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as FOLOTYN (DIN 02481820) under ATC L01BA05 PRALATREXATE%. Indications are not published in the Drug Product Database —… | DIN02481820 | approvedsource: Marketed | health-canada-dpd |
| Jan 15, 2019 | Fulvestrant | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEVA-FULVESTRANT INJECTION (DIN 02460130) under ATC L02BA03 FULVESTRANT. Indications are not published in the Drug… | DIN02460130 | approvedsource: Marketed | health-canada-dpd |
| Jan 14, 2019 | Apalutamide | EMA EU | Nonmetastatic Castration-Resistant Prostate Carcinoma | Erleada is indicated: in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk… | centralisedEMEA/H/C/004452 | approved | ema |
| Jan 14, 2019 | Cabozantinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-01-14 (see label) | SUPPLNDA208692 | approved | openfda |
| Jan 8, 2019 | Docetaxel | FDA US | cancer not stated in this record | Efficacy supplement 2019-01-08 (see label) | SUPPLNDA022534 | approved | openfda |
| Jan 3, 2019 | Pegaspargase | FDA US | cancer not stated in this record | Efficacy supplement 2019-01-03 (see label) | SUPPLBLA103411 | approved | openfda |
| Tagraxofusp |
| FDA US |
| Blastic Plasmacytoid Dendritic Cell Neoplasm |
| ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years… |
| ORIGBLA761116 |
| approved |
| openfda |
| Dec 21, 2018 | Dasatinib | FDA US | cancer not stated in this record | Efficacy supplement 2018-12-21 (see label) | SUPPLNDA021986 | approved | openfda |
| Dec 21, 2018 | Brigatinib | FDA US | cancer not stated in this record | Efficacy supplement 2018-12-21 (see label) | SUPPLNDA208772 | approved | openfda |
| Dec 20, 2018 | Calaspargase Pegol | FDA US | Acute Lymphoblastic Leukemia | ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute… | ORIGBLA761102 | approved | openfda |
| Dec 19, 2018 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2018-12-19 (see label) | SUPPLBLA125514 | approved | openfda |
| Dec 19, 2018 | Olaparib | FDA US | cancer not stated in this record | Efficacy supplement 2018-12-19 (see label) | SUPPLNDA208558 | approved | openfda |
| Dec 14, 2018 | Trastuzumab | FDA US | cancer not stated in this record | Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ( 1 , 2.2 ) | ORIGBLA761091 | approved | openfda |
| Dec 14, 2018 | Trastuzumab | FDA US | Gastroesophageal Junction Adenocarcinoma | the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. | ORIGBLA761091 | approved | openfda |
| Dec 14, 2018 | Trastuzumab | FDA US | Malignant Breast Neoplasm | the treatment of HER2-overexpressing breast cancer. | ORIGBLA761091 | approved | openfda |