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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 15 hours 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, 2025 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-23 (see label) | SUPPLNDA207103 | approved | openfda |
| Apr 22, 2025 | Tislelizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-22 (see label) | SUPPLBLA761232 | approved | openfda |
| Apr 22, 2025 | Tislelizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-22 (see label) | SUPPLBLA761232 | approved | openfda |
| Apr 22, 2025 | Tislelizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-22 (see label) | SUPPLBLA761232 | approved | openfda |
| Apr 22, 2025 | Tislelizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-22 (see label) | SUPPLBLA761232 | approved | openfda |
| Apr 22, 2025 | Tislelizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-22 (see label) | SUPPLBLA761232 | approved | openfda |
| Apr 22, 2025 | Tislelizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-22 (see label) | SUPPLBLA761232 | approved | openfda |
| Apr 22, 2025 | Meloxicam | FDA US | cancer not stated in this record | QAMZOVA is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.… | ORIGNDA217593 | approved | openfda |
| Apr 21, 2025 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-21 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 15, 2025 | Belzutifan | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-15 (see label) | SUPPLNDA215383 | approved | openfda |
| Apr 15, 2025 | Belzutifan | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-15 (see label) | SUPPLNDA215383 | approved | openfda |
| Apr 14, 2025 | Carmustine | Health Canada CA | cancer not stated in this record | Marketed in Canada as BICNU (DIN 02555093) under ATC L01AD01 CARMUSTINE. Indications are not published in the Drug Product Database — see… | DIN02555093 | withdrawnsource: Cancelled Post Marketsince Mar 11, 2026 | health-canada-dpd |
| Apr 11, 2025 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-11 (see label) | SUPPLBLA125554 | approved | openfda |
| Apr 11, 2025 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-11 (see label) | SUPPLBLA125377 | approved | openfda |
| Apr 10, 2025 | Daratumumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-10 (see label) | SUPPLBLA761036 | approved | openfda |
| Apr 10, 2025 | Inavolisib | Health Canada CA | cancer not stated in this record | Marketed in Canada as ITOVEBI (DIN 02555484) under ATC L01EM06 INAVOLISIB. Indications are not published in the Drug Product Database — see… | DIN02555484 | approvedsource: Marketed | health-canada-dpd |
| Apr 10, 2025 | Inavolisib | Health Canada CA | cancer not stated in this record | Marketed in Canada as ITOVEBI (DIN 02555476) under ATC L01EM06 INAVOLISIB. Indications are not published in the Drug Product Database — see… | DIN02555476 | approvedsource: Marketed | health-canada-dpd |
| Apr 10, 2025 | Cabazitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as CABAZITAXEL FOR INJECTION (DIN 02553791) under ATC L01CD04 CABAZITAXEL. Indications are not published in the Drug… | DIN02553791 | approvedsource: Marketed | health-canada-dpd |
| Apr 10, 2025 | Cabazitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as CABAZITAXEL FOR INJECTION (DIN 02553783) under ATC L01CD04 CABAZITAXEL. Indications are not published in the Drug… | DIN02553783 | approvedsource: Marketed | health-canada-dpd |
| Apr 9, 2025 | Larotrectinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-09 (see label) | SUPPLNDA211710 | approved | openfda |
| Apr 9, 2025 | Larotrectinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-09 (see label) | SUPPLNDA210861 | approved | openfda |
| Apr 8, 2025 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-08 (see label) | SUPPLBLA125554 | approved | openfda |
| Apr 8, 2025 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-08 (see label) | SUPPLBLA125377 | approved | openfda |
| Apr 7, 2025 | Ramucirumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-07 (see label) | SUPPLBLA125477 | approved | openfda |
| Apr 7, 2025 | Dexamethasone | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-07 (see label) | SUPPLNDA208742 | approved | openfda |
| Apr 4, 2025 | Datopotamab Deruxtecan | EMA EU | Malignant Breast Neoplasm | Breast cancerDatroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor… | centralisedEMEA/H/C/006547 | approved | ema |
| Apr 1, 2025 | Zolbetuximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as VYLOY (DIN 02553996) under ATC L01FX31 ZOLBETUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02553996 | approvedsource: Marketed | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 28, 2025 | 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 28, 2025 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-02-28 (see label) | SUPPLBLA761069 | approved | openfda |
| Feb 21, 2025 |
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.
| centralisedEMEA/H/C/006407 |
| approved |
| ema |
| Mar 28, 2025 | Tisotumab Vedotin | EMA EU | Malignant Cervical Neoplasm | Tivdak as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease… | centralisedEMEA/H/C/005363 | approved | ema |
| Mar 28, 2025 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-28 (see label) | SUPPLBLA761069 | approved | openfda |
| Mar 26, 2025 | Cabozantinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-26 (see label) | SUPPLNDA208692 | approved | openfda |
| Mar 25, 2025 | Denosumab | FDA US | cancer not stated in this record | of postmenopausal women with osteoporosis at high risk for fracture • to increase bone mass in men with osteoporosis at high risk for… | ORIGBLA761398 | approved | openfda |
| Mar 25, 2025 | Denosumab | FDA US | Malignant Breast Neoplasm | to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer | ORIGBLA761398 | approved | openfda |
| Mar 25, 2025 | Denosumab | FDA US | Malignant Prostate Neoplasm | to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer | ORIGBLA761398 | approved | openfda |
| Mar 19, 2025 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-19 (see label) | SUPPLBLA125514 | approved | openfda |
| Mar 12, 2025 | Encorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-12 (see label) | SUPPLNDA210496 | approved | openfda |
| Mar 12, 2025 | Binimetinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-12 (see label) | SUPPLNDA210498 | approved | openfda |
| Mar 7, 2025 | Trametinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-07 (see label) | SUPPLNDA217513 | approved | openfda |
| Mar 7, 2025 | Trametinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-07 (see label) | SUPPLNDA204114 | approved | openfda |
| Mar 7, 2025 | Dabrafenib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-07 (see label) | SUPPLNDA202806 | approved | openfda |
| Mar 7, 2025 | Dabrafenib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-07 (see label) | SUPPLNDA217514 | approved | openfda |
| Mar 4, 2025 | Talquetamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TALVEY (DIN 02547406) under ATC L01FX29 TALQUETAMAB. Indications are not published in the Drug Product Database — see… | DIN02547406 | approvedsource: Marketed | health-canada-dpd |
| Mar 4, 2025 | Talquetamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TALVEY (DIN 02547392) under ATC L01FX29 TALQUETAMAB. Indications are not published in the Drug Product Database — see… | DIN02547392 | approvedsource: Marketed | health-canada-dpd |
| Tofacitinib |
| FDA US |
| cancer not stated in this record |
| Efficacy supplement 2025-02-21 (see label) |
| SUPPLNDA213082 |
| approved |
| openfda |
| Feb 21, 2025 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-02-21 (see label) | SUPPLNDA208246 | approved | openfda |
| Feb 21, 2025 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-02-21 (see label) | SUPPLNDA203214 | approved | openfda |
| Feb 19, 2025 | Nilotinib | FDA US | cancer not stated in this record | Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. | ORIGNDA218922 | approved | openfda |
| Feb 19, 2025 | Nilotinib | FDA US | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included… | ORIGNDA218922 | approved | openfda |
| Feb 14, 2025 | Vimseltinib | FDA US | cancer not stated in this record | ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection… | ORIGNDA219304 | approved | openfda |