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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Jun 17, 2021 | Azacitidine | EMA EU | Acute Myeloid Leukemia | Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or… | centralisedEMEA/H/C/004761 | approved | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 19, 2021 | Duvelisib | EMA EU | cancer not stated in this record | Copiktra monotherapy is indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukaemia (CLL)… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 26, 2021 | Abiraterone | EMA EU | Castration-Resistant Prostate Carcinoma | Abiraterone Accord is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 26, 2021 | Bevacizumab | EMA EU | cancer not stated in this record | Oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 11, 2021 | Lenalidomide | EMA EU | cancer not stated in this record | Multiple myelomaLenalidomide krka d.d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 11, 2021 | Bevacizumab | EMA EU | cancer not stated in this record | Onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 21, 2020 | Trastuzumab | EMA EU | Early Stage Breast Carcinoma | Early breast cancer (EBC) Phesgo is indicated for use in combination with chemotherapy in: the neoadjuvant treatment of adult patients with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 18, 2020 | 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 |
|---|---|---|---|---|---|---|---|
| Sep 24, 2020 | Avapritinib | EMA EU | cancer not stated in this record | Unresectable or metastatic gastrointestinal stromal tumour (GIST) AYVAKYT is indicated as monotherapy for the treatment of adult patients… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 28, 2020 | Cabazitaxel | EMA EU | Malignant Prostate Neoplasm | Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 31, 2020 | Entrectinib | EMA EU | Tumor-agnosticLung Non-Small Cell Carcinoma | Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 26, 2020 | Glasdegib | EMA EU | Secondary Acute Myeloid Leukemia | Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 30, 2020 | Isatuximab | EMA EU | Multiple Myeloma | Sarclisa is indicated: In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 3, 2020 | Cinacalcet | EMA EU | cancer not stated in this record | Secondary hyperparathyroidism AdultsTreatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD)… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 27, 2020 | Azacitidine | EMA EU | cancer not stated in this record | Azacitidine Mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT)… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 13, 2020 | Azacitidine | EMA EU | cancer not stated in this record | Azacitidine Accord is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 16, 2020 | Polatuzumab Vedotin | EMA EU | Diffuse Large B-Cell Lymphoma | Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 19, 2019 | 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 |
|---|---|---|---|---|---|---|---|
| Nov 14, 2019 | Arsenic Trioxide | EMA EU | Acute Promyelocytic Leukemia | Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate… |
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/005381 |
| withdrawnsince Feb 16, 2026 |
| ema |
| centralisedEMEA/H/C/005408 |
| approved |
| ema |
| Apr 21, 2021 | Bevacizumab | EMA EU | cancer not stated in this record | Abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of… | centralisedEMEA/H/C/005327 | approved | ema |
| Apr 21, 2021 | Dostarlimab | EMA EU | Malignant Endometrial Neoplasm | Jemperli is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced… | centralisedEMEA/H/C/005204 | approved | ema |
| centralisedEMEA/H/C/005556 |
| approved |
| ema |
| Mar 26, 2021 | Thiotepa | EMA EU | cancer not stated in this record | Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as… | centralisedEMEA/H/C/005434 | approved | ema |
| Mar 26, 2021 | Bevacizumab | EMA EU | cancer not stated in this record | Alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of… | centralisedEMEA/H/C/005286 | approved | ema |
| Mar 26, 2021 | Pemigatinib | EMA EU | Cholangiocarcinoma | Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast… | centralisedEMEA/H/C/005266 | approved | ema |
| Mar 26, 2021 | Selinexor | EMA EU | Multiple Myeloma | NEXPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have… | centralisedEMEA/H/C/005127 | approved | ema |
| centralisedEMEA/H/C/005734 |
| approved |
| ema |
| Feb 11, 2021 | Lenalidomide | EMA EU | cancer not stated in this record | Multiple myeloma Lenalidomide Krka d.d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed… | centralisedEMEA/H/C/005729 | withdrawn | ema |
| Feb 11, 2021 | Sunitinib | EMA EU | cancer not stated in this record | Gastrointestinal stromal tumour (GIST) Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant… | centralisedEMEA/H/C/005419 | approved | ema |
| Feb 11, 2021 | Selpercatinib | EMA EU | Tumor-agnostic | Retsevmo as monotherapy is indicated for the treatment of adults with: advanced RET fusion positive non small cell lung cancer (NSCLC) not… | centralisedEMEA/H/C/005375 | approved | ema |
| Feb 11, 2021 | Lenalidomide | EMA EU | cancer not stated in this record | Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple… | centralisedEMEA/H/C/005348 | approved | ema |
| Feb 11, 2021 | Tucatinib | EMA EU | Malignant Breast Neoplasm | Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2?positive locally… | centralisedEMEA/H/C/005263 | approved | ema |
| Feb 8, 2021 | Moxetumomab Pasudotox | EMA EU | Hairy Cell Leukemia | Lumoxiti as monotherapy is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) after… | centralisedEMEA/H/C/005322 | withdrawn | ema |
| Feb 8, 2021 | Fedratinib | EMA EU | cancer not stated in this record | Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post… | centralisedEMEA/H/C/005026 | approved | ema |
| centralisedEMEA/H/C/005640 |
| withdrawn |
| ema |
| Jan 7, 2021 | Tagraxofusp | EMA EU | Blastic Plasmacytoid Dendritic Cell Neoplasm | Elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm… | centralisedEMEA/H/C/005031 | approved | ema |
| centralisedEMEA/H/C/005386 |
| approved |
| ema |
| Dec 21, 2020 | Pertuzumab | EMA EU | Early Stage Breast Carcinoma | Early breast cancer (EBC) Phesgo is indicated for use in combination with chemotherapy in: the neoadjuvant treatment of adult patients with… | centralisedEMEA/H/C/005386 | approved | ema |
| Dec 18, 2020 | Lenalidomide | EMA EU | cancer not stated in this record | Multiple myeloma Lenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed… | centralisedEMEA/H/C/005306 | approved | ema |
| Dec 14, 2020 | Brexucabtagene Autoleucel | EMA EU | cancer not stated in this record | Mantle cell lymphoma Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after… | centralisedEMEA/H/C/005102 | approved | ema |
| centralisedEMEA/H/C/005085 |
| approved |
| ema |
| Nov 16, 2020 | Melphalan | EMA EU | cancer not stated in this record | High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in… | centralisedEMEA/H/C/005173 | approved | ema |
| Nov 5, 2020 | Acalabrutinib | EMA EU | cancer not stated in this record | Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated… | centralisedEMEA/H/C/005299 | approved | ema |
| centralisedEMEA/H/C/005208 |
| approved |
| ema |
| Sep 24, 2020 | Bevacizumab | EMA EU | cancer not stated in this record | Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma… | centralisedEMEA/H/C/005181 | withdrawn | ema |
| Sep 17, 2020 | Arsenic Trioxide | EMA EU | Acute Promyelocytic Leukemia | Arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed… | centralisedEMEA/H/C/005218 | approved | ema |
| centralisedEMEA/H/C/005178 |
| approved |
| ema |
| Aug 25, 2020 | Belantamab Mafodotin | EMA EU | Multiple Myeloma | Blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior… | centralisedEMEA/H/C/004935 | withdrawnsince Feb 23, 2024 | ema |
| Aug 19, 2020 | Bevacizumab | EMA EU | cancer not stated in this record | Aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of… | centralisedEMEA/H/C/005106 | approved | ema |
| centralisedEMEA/H/C/004936 |
| approved |
| ema |
| Jul 27, 2020 | Trastuzumab | EMA EU | cancer not stated in this record | Breast cancer Metastatic breast cancer Zercepac is indicated for the treatment of adult patients with HER2 positive metastatic breast… | centralisedEMEA/H/C/005209 | approved | ema |
| Jul 27, 2020 | Alpelisib | EMA EU | Malignant Breast Neoplasm | Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor… | centralisedEMEA/H/C/004804 | approved | ema |
| centralisedEMEA/H/C/004878 |
| approved |
| ema |
| centralisedEMEA/H/C/004977 |
| approved |
| ema |
| centralisedEMEA/H/C/005236 |
| approved |
| ema |
| Apr 1, 2020 | Arsenic Trioxide | EMA EU | Acute Promyelocytic Leukemia | Arsenic trioxide Mylan is indicated for induction of remission, and consolidation in adult patients with:- Newly diagnosed low to… | centralisedEMEA/H/C/005235 | withdrawnsince Apr 14, 2025 | ema |
| Apr 1, 2020 | Rituximab | EMA EU | cancer not stated in this record | Ruxience is indicated in adults for the following indications: Non?Hodgkin’s lymphoma (NHL) Ruxience is indicated for the treatment of… | centralisedEMEA/H/C/004696 | approved | ema |
| centralisedEMEA/H/C/004984 |
| approved |
| ema |
| Mar 27, 2020 | Darolutamide | EMA EU | Nonmetastatic Castration-Resistant Prostate Carcinoma | NUBEQA is indicated for the treatment of adult men with non‑metastatic castration resistant prostate cancer (nmCRPC) who are at high risk… | centralisedEMEA/H/C/004790 | approved | ema |
| Mar 24, 2020 | Azacitidine | EMA EU | cancer not stated in this record | Azacitidine betapharm is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation… | centralisedEMEA/H/C/005075 | approved | ema |
| centralisedEMEA/H/C/005147 |
| approved |
| ema |
| centralisedEMEA/H/C/004870 |
| approved |
| ema |
| centralisedEMEA/H/C/005312 |
| approved |
| ema |
| centralisedEMEA/H/C/005175 |
| approved |
| ema |
| Nov 14, 2019 | Bortezomib | EMA EU | cancer not stated in this record | Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult… | centralisedEMEA/H/C/005074 | approved | ema |
| Nov 14, 2019 | Clofarabine | EMA EU | Acute Lymphoblastic Leukemia | Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two… | centralisedEMEA/H/C/005039 | withdrawnsince Oct 18, 2023 | ema |