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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
179
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 44 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated yesterdaySource 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 |
|---|---|---|---|---|---|---|---|
| Aug 3, 2022 | Acalabrutinib | FDA US | cancer not stated in this record | For the treatment of adult patients with MCL who have received at least one prior therapy. • For the treatment of adult patients with… | ORIGNDA216387 | approved | openfda |
| Aug 3, 2022 | Acalabrutinib | FDA US | Mantle Cell Lymphoma | In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who… | ORIGNDA216387 | approved | openfda |
| Aug 3, 2022 | Acalabrutinib | FDA US | cancer not stated in this record | For the treatment of adult patients with MCL who have received at least one prior therapy. • For the treatment of adult patients with… | ORIGNDA216387 | approved | openfda |
| Aug 3, 2022 | Acalabrutinib | FDA US | Mantle Cell Lymphoma | In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who… | ORIGNDA216387 | approved | openfda |
| Aug 1, 2022 | Azacitidine | Health Canada CA | cancer not stated in this record | Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02501791) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug… | DIN02501791 | withdrawnsource: Dormantsince Jul 31, 2025 | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 29, 2022 | Roflumilast | FDA US | cancer not stated in this record | ZORYVE cream is a phosphodiesterase 4 inhibitor: Plaque Psoriasis ZORYVE cream, 0.3%, is indicated for the topical treatment of plaque… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 30, 2022 | Carfilzomib | FDA US | cancer not stated in this record | Efficacy supplement 2022-06-30 (see label) | SUPPLNDA202714 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 31, 2022 | Doxorubicin | EMA EU | cancer not stated in this record | Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults: • breast cancer that has spread to other… |
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.
| ORIGNDA215985 |
| approved |
| openfda |
| Jul 28, 2022 | Cobimetinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-07-28 (see label) | SUPPLNDA206192 | approved | openfda |
| Jul 27, 2022 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP TEMOZOLOMIDE (DIN 02516799) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product… | DIN02516799 | approvedsource: Marketed | health-canada-dpd |
| Jul 27, 2022 | Paclitaxel | FDA US | Pancreatic Adenocarcinoma | Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. | ORIGNDA211875 | approved | openfda |
| Jul 27, 2022 | Paclitaxel | FDA US | Lung Non-Small Cell Carcinoma | Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who… | ORIGNDA211875 | approved | openfda |
| Jul 27, 2022 | Paclitaxel | FDA US | Malignant Breast Neoplasm | Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant… | ORIGNDA211875 | approved | openfda |
| Jul 27, 2022 | Bortezomib | FDA US | Mantle Cell Lymphoma | treatment of adult patients with mantle cell lymphoma | ORIGNDA215331 | approved | openfda |
| Jul 27, 2022 | Bortezomib | FDA US | Multiple Myeloma | treatment of adult patients with multiple myeloma | ORIGNDA215331 | approved | openfda |
| Jul 26, 2022 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP TEMOZOLOMIDE (DIN 02516845) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product… | DIN02516845 | approvedsource: Marketed | health-canada-dpd |
| Jul 26, 2022 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP TEMOZOLOMIDE (DIN 02516829) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product… | DIN02516829 | approvedsource: Marketed | health-canada-dpd |
| Jul 25, 2022 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP TEMOZOLOMIDE (DIN 02516810) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product… | DIN02516810 | approvedsource: Marketed | health-canada-dpd |
| Jul 20, 2022 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as ONTRUZANT (DIN 02524325) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database —… | DIN02524325 | approvedsource: Marketed | health-canada-dpd |
| Jul 20, 2022 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as ONTRUZANT (DIN 02524317) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database —… | DIN02524317 | approvedsource: Marketed | health-canada-dpd |
| Jul 18, 2022 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as LETROZOLE (DIN 02524244) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database —… | DIN02524244 | approvedsource: Marketed | health-canada-dpd |
| Jul 18, 2022 | Bortezomib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARO-BORTEZOMIB (DIN 02511932) under ATC L01XG01 BORTEZOMIB. Indications are not published in the Drug Product… | DIN02511932 | approvedsource: Marketed | health-canada-dpd |
| Jul 18, 2022 | Ruxolitinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-07-18 (see label) | SUPPLNDA215309 | approved | openfda |
| Jul 15, 2022 | Avelumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-07-15 (see label) | SUPPLBLA761049 | approved | openfda |
| Jul 14, 2022 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-07-14 (see label) | SUPPLBLA125554 | approved | openfda |
| Jul 14, 2022 | Crizotinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-07-14 (see label) | SUPPLNDA202570 | approved | openfda |
| Jul 14, 2022 | Cabozantinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-07-14 (see label) | SUPPLNDA208692 | approved | openfda |
| Jul 13, 2022 | Oxaliplatin | Health Canada CA | cancer not stated in this record | Marketed in Canada as OXALIPLATIN INJECTION, USP (DIN 02458403) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug… | DIN02458403 | approvedsource: Marketed | health-canada-dpd |
| Jul 12, 2022 | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as ABIRATERONE (DIN 02525380) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product Database… | DIN02525380 | withdrawnsource: Dormantsince Jul 31, 2025 | health-canada-dpd |
| Jul 7, 2022 | Selinexor | Health Canada CA | cancer not stated in this record | Marketed in Canada as XPOVIO (DIN 02527677) under ATC L01XX66 SELINEXOR. Indications are not published in the Drug Product Database — see… | DIN02527677 | approvedsource: Marketed | health-canada-dpd |
| Jun 27, 2022 | Bevacizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as AYBINTIO (DIN 02522837) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database —… | DIN02522837 | approvedsource: Marketed | health-canada-dpd |
| Jun 27, 2022 | Bevacizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as AYBINTIO (DIN 02522829) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database —… | DIN02522829 | approvedsource: Marketed | health-canada-dpd |
| Jun 22, 2022 | Trametinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-06-22 (see label) | SUPPLNDA204114 | approved | openfda |
| Jun 22, 2022 | Pemetrexed | FDA US | Pleural Malignant Mesothelioma | Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are… | ORIGNDA214218 | approved | openfda |
| Jun 22, 2022 | Pemetrexed | FDA US | Lung Non-Small Cell Carcinoma | Limitations of Use : Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | ORIGNDA214218 | approved | openfda |
| Jun 22, 2022 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | ORIGNDA214218 | approved | openfda |
| Jun 22, 2022 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not… | ORIGNDA214218 | approved | openfda |
| Jun 22, 2022 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung… | ORIGNDA214218 | approved | openfda |
| Jun 22, 2022 | Dabrafenib | FDA US | cancer not stated in this record | Efficacy supplement 2022-06-22 (see label) | SUPPLNDA202806 | approved | openfda |
| Jun 20, 2022 | Capmatinib | EMA EU | Lung Non-Small Cell Carcinoma | Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (NSCLC) harbouring… | centralisedEMEA/H/C/004845 | approved | ema |
| Jun 17, 2022 | Pemetrexed | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEMETREXED FOR INJECTION, USP (DIN 02463091) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug… | DIN02463091 | approvedsource: Marketed | health-canada-dpd |
| Jun 17, 2022 | Pemetrexed | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEMETREXED FOR INJECTION, USP (DIN 02463083) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug… | DIN02463083 | approvedsource: Marketed | health-canada-dpd |
| Jun 16, 2022 | Capecitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CAPECITABINE (DIN 02519887) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product… | DIN02519887 | approvedsource: Marketed | health-canada-dpd |
| Jun 15, 2022 | Capecitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CAPECITABINE (DIN 02519879) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product… | DIN02519879 | approvedsource: Marketed | health-canada-dpd |
| Jun 10, 2022 | Rucaparib | FDA US | cancer not stated in this record | Efficacy supplement 2022-06-10 (see label) | SUPPLNDA209115 | approved | openfda |
| Jun 3, 2022 | Mosunetuzumab | EMA EU | Follicular Lymphoma | Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have… | centralisedEMEA/H/C/005680 | approved | ema |
| centralisedEMEA/H/C/005320 |
| approved |
| ema |
| May 27, 2022 | Trametinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-27 (see label) | SUPPLNDA204114 | approved | openfda |
| May 27, 2022 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-27 (see label) | SUPPLBLA125554 | approved | openfda |
| May 27, 2022 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-27 (see label) | SUPPLBLA125554 | approved | openfda |
| May 27, 2022 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-27 (see label) | SUPPLBLA125377 | approved | openfda |