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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| May 27, 2022 | Dabrafenib | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-27 (see label) | SUPPLNDA202806 | approved | openfda |
| May 26, 2022 | Pegfilgrastim | FDA US | cancer not stated in this record | FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients… | ORIGBLA761084 | approved | openfda |
| May 26, 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… | ORIGNDA214657 | approved | openfda |
| May 26, 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. | ORIGNDA214657 | approved | openfda |
| May 26, 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. | ORIGNDA214657 | approved | openfda |
| May 26, 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… | ORIGNDA214657 | approved | openfda |
| May 26, 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 NSCLC. | ORIGNDA214657 | approved | openfda |
| May 26, 2022 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small… | ORIGNDA214657 | approved | openfda |
| May 25, 2022 | Ciltacabtagene Autoleucel | EMA EU | Multiple Myeloma | Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one… | centralisedEMEA/H/C/005095 | approved | ema |
| May 25, 2022 | Ivosidenib | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-25 (see label) | SUPPLNDA211192 | approved | openfda |
| May 24, 2022 | Leuprolide | EMA EU | Malignant Prostate Neoplasm | Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and… | centralisedEMEA/H/C/005034 | approved | ema |
| May 20, 2022 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-20 (see label) | SUPPLBLA125514 | approved | openfda |
| May 20, 2022 | Azacitidine | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-20 (see label) | SUPPLNDA050794 | approved | openfda |
| May 19, 2022 | Irinotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as IRINOTECAN HYDROCHLORIDE INJECTION (DIN 02501295) under ATC L01CE02 IRINOTECAN. Indications are not published in the… | DIN02501295 | approvedsource: Marketed | health-canada-dpd |
| May 19, 2022 | Irinotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as IRINOTECAN HYDROCHLORIDE INJECTION (DIN 02501279) under ATC L01CE02 IRINOTECAN. Indications are not published in the… | DIN02501279 | approvedsource: Marketed | health-canada-dpd |
| May 11, 2022 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-11 (see label) | SUPPLBLA125554 | approved | openfda |
| May 11, 2022 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-11 (see label) | SUPPLBLA125377 | approved | openfda |
| May 10, 2022 | Pemetrexed | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEMETREXED FOR INJECTION (DIN 02515423) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug… | DIN02515423 | approvedsource: Marketed | health-canada-dpd |
| May 4, 2022 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-04 (see label) | SUPPLBLA761139 | approved | openfda |
| May 4, 2022 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-04 (see label) | SUPPLBLA761139 | approved | openfda |
| May 4, 2022 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-04 (see label) | SUPPLBLA761139 | approved | openfda |
| May 4, 2022 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2022-05-04 (see label) | SUPPLBLA761139 | approved | openfda |
| May 2, 2022 | Bortezomib | FDA US | Mantle Cell Lymphoma | Treatment of adult patients with mantle cell lymphoma. | ORIGNDA209191 | approved | openfda |
| May 2, 2022 | Bortezomib | FDA US | Multiple Myeloma | Treatment of adult patients with multiple myeloma. | ORIGNDA209191 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 29, 2022 | Relugolix | EMA EU | Malignant Prostate Neoplasm | Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer. | centralised |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 31, 2022 | Oxaliplatin | Health Canada CA | cancer not stated in this record | Marketed in Canada as OXALIPLATIN INJECTION, USP (DIN 02457423) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug… | DIN02457423 |
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.
| approved |
| ema |
| Apr 28, 2022 | Bicalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as BICALUTAMIDE (DIN 02519178) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product… | DIN02519178 | approvedsource: Marketed | health-canada-dpd |
| Apr 28, 2022 | Ixazomib | FDA US | cancer not stated in this record | Efficacy supplement 2022-04-28 (see label) | SUPPLNDA208462 | approved | openfda |
| Apr 26, 2022 | Amivantamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as RYBREVANT (DIN 02526182) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database —… | DIN02526182 | approvedsource: Marketed | health-canada-dpd |
| Apr 21, 2022 | Cytarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYTARABINE INJECTION (DIN 02515296) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product… | DIN02515296 | approvedsource: Marketed | health-canada-dpd |
| Apr 18, 2022 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2022-04-18 (see label) | SUPPLNDA020517 | approved | openfda |
| Apr 18, 2022 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2022-04-18 (see label) | SUPPLNDA019732 | approved | openfda |
| Apr 13, 2022 | Enfortumab Vedotin | EMA EU | Malignant Bladder Neoplasm | Muscle invasive bladder cancer (MIBC) Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical… | centralisedEMEA/H/C/005392 | approved | ema |
| Apr 13, 2022 | Bevacizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as ABEVMY (DIN 02522179) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see… | DIN02522179 | approvedsource: Marketed | health-canada-dpd |
| Apr 13, 2022 | Bevacizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as ABEVMY (DIN 02522160) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see… | DIN02522160 | approvedsource: Marketed | health-canada-dpd |
| Apr 7, 2022 | Afatinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-04-07 (see label) | SUPPLNDA201292 | approved | openfda |
| Apr 5, 2022 | Alpelisib | FDA US | cancer not stated in this record | VIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of… | ORIGNDA215039 | approved | openfda |
| Apr 4, 2022 | Lisocabtagene Maraleucel | EMA EU | cancer not stated in this record | Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL),… | centralisedEMEA/H/C/004731 | approved | ema |
| Apr 1, 2022 | Tebentafusp | EMA EU | Uveal Melanoma | Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable… | centralisedEMEA/H/C/004929 | approved | ema |
| approvedsource: Marketed |
| health-canada-dpd |
| Mar 28, 2022 | Pegfilgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for… | centralisedEMEA/H/C/004780 | approved | ema |
| Mar 28, 2022 | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as SANDOZ ABIRATERONE (DIN 02521644) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product… | DIN02521644 | approvedsource: Marketed | health-canada-dpd |
| Mar 25, 2022 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as NRA-LETROZOLE (DIN 02520486) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database… | DIN02520486 | approvedsource: Marketed | health-canada-dpd |
| Mar 24, 2022 | Dasatinib | EMA EU | Acute Lymphoblastic Leukemia | Dasatinib Accord is indicated for the treatment of adult patients with: • Ph+ acute lymphoblastic leukaemia (ALL) with resistance or… | centralisedEMEA/H/C/005446 | withdrawn | ema |
| Mar 24, 2022 | Dasatinib | EMA EU | cancer not stated in this record | Dasatinib Accordpharma is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+)… | centralisedEMEA/H/C/005317 | withdrawn | ema |
| Mar 22, 2022 | Elotuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-03-22 (see label) | SUPPLBLA761035 | approved | openfda |
| Mar 22, 2022 | Sirolimus | FDA US | cancer not stated in this record | HYFTOR is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of… | ORIGNDA213478 | approved | openfda |
| Mar 21, 2022 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-03-21 (see label) | SUPPLBLA125514 | approved | openfda |
| Mar 11, 2022 | Arsenic Trioxide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ARSENIC TRIOXIDE FOR INJECTION (DIN 02513420) under ATC L01XX27 ARSENIC TRIOXIDE. Indications are not published in… | DIN02513420 | approvedsource: Marketed | health-canada-dpd |
| Mar 11, 2022 | Olaparib | FDA US | cancer not stated in this record | Efficacy supplement 2022-03-11 (see label) | SUPPLNDA208558 | approved | openfda |
| Mar 4, 2022 | Daratumumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-03-04 (see label) | SUPPLBLA761036 | approved | openfda |