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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 22 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 |
|---|---|---|---|---|---|---|---|
| Jan 5, 2024 | Paclitaxel | EMA EU | cancer not stated in this record | Naveruclif monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment… | centralisedEMEA/H/C/006173 | approved | ema |
| Jan 5, 2024 | Azacitidine | EMA EU | cancer not stated in this record | Azacitidine Kabi is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation(HSCT)… | centralisedEMEA/H/C/006154 | approved | ema |
| Jan 5, 2024 | Adagrasib | EMA EU | Lung Non-Small Cell Carcinoma | Krazati as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C… | centralisedEMEA/H/C/006013 | approved | ema |
| Jan 5, 2024 | Trametinib | EMA EU | High-Grade Glioma, NOS | Low-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older… | centralisedEMEA/H/C/005886 | approved | ema |
| Jan 5, 2024 | Plerixafor | Health Canada CA | cancer not stated in this record | Marketed in Canada as PLERIXAFOR INJECTION (DIN 02539454) under ATC L03AX16 PLERIXAFOR. Indications are not published in the Drug Product… | DIN02539454 | approvedsource: Marketed | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 21, 2023 | Zanubrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-12-21 (see label) | SUPPLNDA213217 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 30, 2023 | Dabrafenib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAFINLAR (DIN 02540053) under ATC L01EC02 DABRAFENIB. Indications are not published in the Drug Product Database —… | DIN02540053 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 31, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-10-31 (see label) | SUPPLBLA125514 | approved | openfda |
| Oct 31, 2023 |
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.
| Dec 19, 2023 | Apalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2023-12-19 (see label) | SUPPLNDA210951 | approved | openfda |
| Dec 18, 2023 | Epcoritamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as EPKINLY (DIN 02542307) under ATC L01FX27 EPCORITAMAB. Indications are not published in the Drug Product Database —… | DIN02542307 | approvedsource: Marketed | health-canada-dpd |
| Dec 18, 2023 | Epcoritamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as EPKINLY (DIN 02542293) under ATC L01FX27 EPCORITAMAB. Indications are not published in the Drug Product Database —… | DIN02542293 | approvedsource: Marketed | health-canada-dpd |
| Dec 18, 2023 | Fulvestrant | Health Canada CA | cancer not stated in this record | Marketed in Canada as FULVESTRANT INJECTION (DIN 02536293) under ATC L02BA03 FULVESTRANT. Indications are not published in the Drug Product… | DIN02536293 | approvedsource: Marketed | health-canada-dpd |
| Dec 15, 2023 | Brexucabtagene Autoleucel | Health Canada CA | cancer not stated in this record | Marketed in Canada as TECARTUS (DIN 02532719) under ATC L01XL06 BREXUCABTAGENE AUTOLEUCEL. Indications are not published in the Drug… | DIN02532719 | approvedsource: Marketed | health-canada-dpd |
| Dec 15, 2023 | Roflumilast | FDA US | cancer not stated in this record | ZORYVE topical foam, 0.3%, is a phosphodiesterase 4 inhibitor indicated for the treatment of seborrheic dermatitis in adult and pediatric… | ORIGNDA217242 | approved | openfda |
| Dec 15, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-12-15 (see label) | SUPPLBLA125514 | approved | openfda |
| Dec 15, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-12-15 (see label) | SUPPLBLA125514 | approved | openfda |
| Dec 15, 2023 | Enfortumab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2023-12-15 (see label) | SUPPLBLA761137 | approved | openfda |
| Dec 15, 2023 | Enfortumab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2023-12-15 (see label) | SUPPLBLA761137 | approved | openfda |
| Dec 14, 2023 | Belzutifan | FDA US | cancer not stated in this record | Efficacy supplement 2023-12-14 (see label) | SUPPLNDA215383 | approved | openfda |
| Dec 11, 2023 | Peginterferon Alfa-2a | FDA US | cancer not stated in this record | Efficacy supplement 2023-12-11 (see label) | SUPPLBLA103964 | approved | openfda |
| Dec 7, 2023 | Elranatamab | EMA EU | Multiple Myeloma | Elrexfio is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received… | centralisedEMEA/H/C/005908 | approved | ema |
| Dec 6, 2023 | Relugolix | Health Canada CA | cancer not stated in this record | Marketed in Canada as ORGOVYX (DIN 02542137) under ATC L02BX04 RELUGOLIX. Indications are not published in the Drug Product Database — see… | DIN02542137 | approvedsource: Marketed | health-canada-dpd |
| Dec 5, 2023 | Dasatinib | FDA US | cancer not stated in this record | 1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive… | ORIGNDA216099 | approved | openfda |
| Dec 1, 2023 | Pirtobrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-12-01 (see label) | SUPPLNDA216059 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Nov 30, 2023 | Trametinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as MEKINIST (DIN 02539993) under ATC L01EE01 TRAMETINIB. Indications are not published in the Drug Product Database —… | DIN02539993 | approvedsource: Marketed | health-canada-dpd |
| Nov 27, 2023 | Nirogacestat | FDA US | cancer not stated in this record | OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase… | ORIGNDA217677 | approved | openfda |
| Nov 21, 2023 | Paclitaxel | FDA US | cancer not stated in this record | Efficacy supplement 2023-11-21 (see label) | SUPPLNDA216338 | approved | openfda |
| Nov 16, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-11-16 (see label) | SUPPLBLA125514 | approved | openfda |
| Nov 16, 2023 | Enzalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2023-11-16 (see label) | SUPPLNDA213674 | approved | openfda |
| Nov 16, 2023 | Enzalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2023-11-16 (see label) | SUPPLNDA203415 | approved | openfda |
| Nov 16, 2023 | Capivasertib | FDA US | Malignant Prostate Neoplasm | PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer • in combination with abiraterone and… | ORIGNDA218197 | approved | openfda |
| Nov 16, 2023 | Capivasertib | FDA US | Malignant Breast Neoplasm | HR positive, HER2 negative locally advanced or metastatic breast cancer • in combination with fulvestrant for the treatment of adult… | ORIGNDA218197 | approved | openfda |
| Nov 15, 2023 | Dabrafenib | EMA EU | High-Grade Glioma, NOS | Low-grade glioma Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with… | centralisedEMEA/H/C/005885 | approved | ema |
| Nov 15, 2023 | Trastuzumab | EMA EU | cancer not stated in this record | Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC). | centralisedEMEA/H/C/005769 | approved | ema |
| Nov 15, 2023 | Repotrectinib | FDA US | Tumor-agnostic | adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene… | ORIGNDA218213 | approved | openfda |
| Nov 15, 2023 | Repotrectinib | FDA US | ROS1-Positive Lung Non-Small Cell Carcinoma | AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small… | ORIGNDA218213 | approved | openfda |
| Nov 13, 2023 | Ibrutinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as IMBRUVICA (DIN 02540215) under ATC L01EL01 IBRUTINIB. Indications are not published in the Drug Product Database —… | DIN02540215 | approvedsource: Marketed | health-canada-dpd |
| Nov 8, 2023 | Fruquintinib | FDA US | Malignant Colorectal Neoplasm | 1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been… | ORIGNDA217564 | approved | openfda |
| Nov 7, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-11-07 (see label) | SUPPLBLA125514 | approved | openfda |
| Nov 6, 2023 | Quizartinib | EMA EU | Acute Myeloid Leukemia | Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation… | centralisedEMEA/H/C/005910 | approved | ema |
| Nov 6, 2023 | Olaparib | FDA US | cancer not stated in this record | Efficacy supplement 2023-11-06 (see label) | SUPPLNDA208558 | approved | openfda |
| Nov 1, 2023 | Isatuximab | FDA US | cancer not stated in this record | Efficacy supplement 2023-11-01 (see label) | SUPPLBLA761113 | approved | openfda |
| Nov 1, 2023 | Apalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ERLEADA (DIN 02540185) under ATC L02BB05 APALUTAMIDE. Indications are not published in the Drug Product Database —… | DIN02540185 | approvedsource: Marketed | health-canada-dpd |
| Pembrolizumab |
| FDA US |
| cancer not stated in this record |
| Efficacy supplement 2023-10-31 (see label) |
| SUPPLBLA125514 |
| approved |
| openfda |
| Oct 30, 2023 | Pirtobrutinib | EMA EU | cancer not stated in this record | Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have… | centralisedEMEA/H/C/005863 | approved | ema |
| Oct 27, 2023 | Toripalimab | FDA US | cancer not stated in this record | as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a… | ORIGBLA761240 | approved | openfda |
| Oct 27, 2023 | Toripalimab | FDA US | Nasopharyngeal Carcinoma | in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced… | ORIGBLA761240 | approved | openfda |
| Oct 27, 2023 | Paclitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as PACLITAXEL POWDER FOR INJECTABLE SUSPENSION NANOPARTICLE, ALBUMIN-BOUND PACLITAXEL (DIN 02496097) under ATC L01CD01… | DIN02496097 | approvedsource: Marketed | health-canada-dpd |
| Oct 24, 2023 | Ivosidenib | FDA US | cancer not stated in this record | Efficacy supplement 2023-10-24 (see label) | SUPPLNDA211192 | approved | openfda |
| Oct 23, 2023 | Tremelimumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as IMJUDO (DIN 02541009) under ATC L01FX20 TREMELIMUMAB. Indications are not published in the Drug Product Database —… | DIN02541009 | approvedsource: Marketed | health-canada-dpd |