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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
183
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 48 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 19 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 |
|---|---|---|---|---|---|---|---|
| Jul 9, 2024 | Roflumilast | FDA US | cancer not stated in this record | Efficacy supplement 2024-07-09 (see label) | SUPPLNDA215985 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 28, 2024 | 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… | ORIG |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 29, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-05-29 (see label) | SUPPLNDA213246 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 29, 2024 | Tisotumab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-29 (see label) | SUPPLBLA761208 | approved | openfda |
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 |
| openfda |
| Jun 28, 2024 | Pemetrexed | FDA US | Lung Non-Small Cell Carcinoma | Limitations of Use: AXTLE is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | ORIGNDA210661 | approved | openfda |
| Jun 28, 2024 | 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. | ORIGNDA210661 | approved | openfda |
| Jun 28, 2024 | 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… | ORIGNDA210661 | approved | openfda |
| Jun 28, 2024 | 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. | ORIGNDA210661 | approved | openfda |
| Jun 28, 2024 | 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… | ORIGNDA210661 | approved | openfda |
| Jun 27, 2024 | Eribulin | EMA EU | cancer not stated in this record | Eribulin Baxter is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed… | centralisedEMEA/H/C/006191 | approved | ema |
| Jun 26, 2024 | Epcoritamab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-26 (see label) | SUPPLBLA761324 | approved | openfda |
| Jun 25, 2024 | Thiotepa | FDA US | Breast Adenocarcinoma | TEPYLUTE is an alkylating drug indicated for treatment of adenocarcinoma of the breast or ovary. | ORIGNDA216984 | approved | openfda |
| Jun 21, 2024 | Adagrasib | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-21 (see label) | SUPPLNDA216340 | approved | openfda |
| Jun 20, 2024 | Fruquintinib | EMA EU | Malignant Colorectal Neoplasm | Fruzaqla as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously… | centralisedEMEA/H/C/005979 | approved | ema |
| Jun 18, 2024 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-18 (see label) | SUPPLBLA103792 | approved | openfda |
| Jun 17, 2024 | Capivasertib | EMA EU | Malignant Breast Neoplasm | Truqap is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive,… | centralisedEMEA/H/C/006017 | approved | ema |
| Jun 17, 2024 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-17 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 14, 2024 | Blinatumomab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-14 (see label) | SUPPLBLA125557 | approved | openfda |
| Jun 14, 2024 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-14 (see label) | SUPPLBLA761069 | approved | openfda |
| Jun 13, 2024 | Repotrectinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-13 (see label) | SUPPLNDA218213 | approved | openfda |
| Jun 12, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-12 (see label) | SUPPLNDA213246 | approved | openfda |
| Jun 12, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-12 (see label) | SUPPLNDA218160 | approved | openfda |
| Jun 7, 2024 | Tirbanibulin | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-07 (see label) | SUPPLNDA213189 | approved | openfda |
| Jun 7, 2024 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-07 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 7, 2024 | Lenvatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-07 (see label) | SUPPLNDA206947 | approved | openfda |
| May 22, 2024 | Irinotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as IRINOTECAN HYDROCHLORIDE INJECTION, USP (DIN 02452421) under ATC L01CE02 IRINOTECAN. Indications are not published in… | DIN02452421 | approvedsource: Marketed | health-canada-dpd |
| May 17, 2024 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in… | centralisedEMEA/H/C/006378 | approved | ema |
| May 16, 2024 | Tarlatamab | FDA US | Lung Small Cell Carcinoma | IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression… | ORIGBLA761344 | approved | openfda |
| May 16, 2024 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab… | centralisedEMEA/H/C/005964 | approved | ema |
| May 16, 2024 | Atezolizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TECENTRIQ SC (DIN 02546310) under ATC L01FF05 ATEZOLIZUMAB. Indications are not published in the Drug Product… | DIN02546310 | approvedsource: Marketed | health-canada-dpd |
| Apr 29, 2024 | Imatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as IMATINIB (DIN 02521210) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see… | DIN02521210 | approvedsource: Marketed | health-canada-dpd |
| Apr 29, 2024 | Imatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as IMATINIB (DIN 02521202) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see… | DIN02521202 | approvedsource: Marketed | health-canada-dpd |
| Apr 24, 2024 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as M-METHOTREXATE (DIN 02534916) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product… | DIN02534916 | approvedsource: Marketed | health-canada-dpd |
| Apr 24, 2024 | Alpelisib | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-24 (see label) | SUPPLNDA215039 | approved | openfda |
| Apr 24, 2024 | 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… | ORIGNDA218466 | approved | openfda |
| Apr 23, 2024 | Tovorafenib | FDA US | cancer not stated in this record | OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG)… | ORIGNDA218033 | approved | openfda |
| Apr 23, 2024 | Tovorafenib | FDA US | cancer not stated in this record | OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG)… | ORIGNDA217700 | approved | openfda |
| Apr 22, 2024 | Nogapendekin Alfa Inbakicept | FDA US | Non-Muscle Invasive Bladder Carcinoma | ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle… | ORIGBLA761336 | approved | openfda |
| Apr 19, 2024 | Retifanlimab | EMA EU | Merkel Cell Carcinoma | Squamous cell carcinoma of the anal canal (SCAC) Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line… | centralisedEMEA/H/C/006194 | approved | ema |
| Apr 19, 2024 | Nintedanib | EMA EU | cancer not stated in this record | Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated… | centralisedEMEA/H/C/006179 | approved | ema |
| Apr 19, 2024 | Tislelizumab | EMA EU | cancer not stated in this record | Non-small cell lung cancer (NSCLC)Tizveni in combination with pemetrexed and platinum-containing chemotherapy is indicated for the… | centralisedEMEA/H/C/005542 | withdrawn | ema |
| Apr 18, 2024 | Alectinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-18 (see label) | SUPPLNDA208434 | approved | openfda |
| Apr 16, 2024 | Capivasertib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRUQAP (DIN 02544733) under ATC L01EX27 CAPIVASERTIB. Indications are not published in the Drug Product Database —… | DIN02544733 | approvedsource: Marketed | health-canada-dpd |
| Apr 11, 2024 | Glatiramer | Health Canada CA | cancer not stated in this record | Marketed in Canada as GLATIRAMER ACETATE INJECTION (DIN 02541440) under ATC L03AX13 GLATIRAMER ACETATE. Indications are not published in… | DIN02541440 | approvedsource: Marketed | health-canada-dpd |
| Apr 10, 2024 | Selpercatinib | FDA US | Tumor-agnostic | Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected… | ORIGNDA218160 | approved | openfda |
| Apr 10, 2024 | Selpercatinib | FDA US | Malignant Thyroid Gland Neoplasm | Adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an… | ORIGNDA218160 | approved | openfda |
| Apr 10, 2024 | Selpercatinib | FDA US | Thyroid Gland Medullary Carcinoma | Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as… | ORIGNDA218160 | approved | openfda |
| Apr 10, 2024 | Selpercatinib | FDA US | Lung Non-Small Cell Carcinoma | Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene… | ORIGNDA218160 | approved | openfda |
| Apr 5, 2024 | Cemiplimab | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-05 (see label) | SUPPLBLA761097 | approved | openfda |
| Apr 5, 2024 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-05 (see label) | SUPPLBLA761139 | approved | openfda |