2026-02-05Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency
2025-12-17FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injectionDrug Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) · Anti-EGFR-HGFR bispecific antibody
2025-11-19FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromasTrial KOMETDrug KOSELUGO (selumetinib) · MEK inhibitor
2025-11-13FDA approves new interchangeable biosimilar to PerjetaDrugs Poherdy (pertuzumab-dpzb) · Anti-HER2 antibody, Perjeta (pertuzumab) · Anti-HER2 antibody
2025-09-19FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injectionTrial MK-3475A-D77Drug Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) · Anti-PD-1 antibody
2025-09-10FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromasDrug KOSELUGO (selumetinib) · MEK inhibitor
2025-02-11FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resectionTrial ReNeuDrug Gomekli (mirdametinib)
2025-01-24Safety announcement: FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5FU treatment
2024-12-27FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injectionTrial CheckMate-67TDrugs Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) · Anti-PD-1 antibody, Opdivo (nivolumab) · Anti-PD-1 antibody
2024-12-18FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patientsDrug Ryoncil (remestemcel-L-rknd) · Cellular therapyConditionOther
2024-09-12FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injectionDrug Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) · Anti-PD-L1 antibody
2024-08-14FDA approves axatilimab-csfr for chronic graft-versus-host diseaseTrial AGAVE-201Drug Niktimvo (axatilimab-csfr) · Anti-CSF1R antibodyConditionOther
2024-03-21FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products
2023-10-20FDA expands pediatric indication for entrectinib and approves new pellet formulationTrial STARTRK-NGDrug Rozlytrek (entrectinib) · TRK inhibitor
2023-09-14FDA approves new and updated indications for temozolomide under Project RenewalDrug Temodar (temozolomide) · Triazene
2023-04-17FDA approves omidubicel to reduce time to neutrophil recovery and infection in patients with hematologic malignanciesDrug Omisirge (omidubicel-onlv)
2022-12-14FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal
2022-11-18FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)Drug Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) · Asparagine-specific enzyme
2022-08-24FDA approves ibrutinib for pediatric patients with chronic graft versus host disease, including a new oral suspensionDrug Imbruvica (ibrutinib) · BTK inhibitorConditionOther
2022-04-06FDA approves alpelisib for PIK3CA-related overgrowth spectrumTrial EPIK-P1Drug Vijoice (alpelisib) · PI3K alpha inhibitor
2021-12-15FDA approves abatacept for prophylaxis of acute graft versus host diseaseDrug Orencia (abatacept) ConditionOther
2021-12-02FDA approves rituximab plus chemotherapy for pediatric cancer indicationsDrug Rituxan (rituximab) · Anti-CD20 antibodyConditionOther neoplasm
2021-09-22FDA approves ruxolitinib for chronic graft-versus-host diseaseDrug Jakafi (ruxolitinib) · JAK inhibitorConditionOther
2021-08-13FDA approves belzutifan for cancers associated with von Hippel-Lindau diseaseTrial MK-6482-004Drug Welireg (belzutifan) · HIF-2a inhibitor
2021-07-16FDA approves belumosudil for chronic graft-versus-host diseaseDrug Rezurock (belumosudil) · ROCK2 inhibitorConditionOther
2020-10-26FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers
2020-04-28FDA approves new dosing regimen for pembrolizumabTrial KEYNOTE-555Drugs KEYTRUDA (400 mg every six weeks for pembrolizumab) , KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
2020-04-10FDA approves selumetinib for neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromasDrug KOSELUGO (selumetinib) · MEK inhibitor
2019-11-25FDA approves voxelotor for sickle cell diseaseTrial GBT_HOPEDrug Oxbryta (voxelotor) · Hemoglobin S polymerization inhibitorConditionClassical hematology
2019-11-15FDA approves crizanlizumab-tmca for sickle cell diseaseTrial SUSTAINDrug ADAKVEO (crizanlizumab-tmca) · Anti-P-selectin antibodyConditionClassical hematology
2019-11-08FDA approves luspatercept-aamt for anemia in patients with beta thalassemiaTrial BELIEVEDrug REBLOZYL (luspatercept-aamt) · TGF-beta inhibitorConditionClassical hematology
2019-11-05FDA Office of Hematology Oncology Products Reorganizes, Renamed Office of Oncologic Diseases
2019-09-17Simultaneous review decisions for pembrolizumab plus lenvatinib in Australia, Canada and USDrugs KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, LENVIMA (lenvatinib) · Multikinase inhibitor
2019-05-24FDA approves ruxolitinib for acute graft-versus-host diseaseDrug JAKAFI (ruxolitinib) · JAK inhibitorConditionOther
2019-05-16FDA approves dalteparin sodium for VTE in pediatric patientsDrug FRAGMIN (dalteparin sodium) · Low molecular weight heparinConditionClassical hematology
2019-02-28FDA approves new formulation of Herceptin for subcutaneous useTrial SafeHERDrug Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) · Anti-HER2 antibody
2019-02-06FDA approved caplacizumab-yhdpTrial HERCULESDrug CABLIVI (caplacizumab-yhdp) · Anti-vWF antibody
2018-12-20FDA approves longer-acting calaspargase pegol-mknl for ALLDrug ASPARLAS (calaspargase pegol-mknl) · Asparagine-specific enzyme
2018-12-14FDA approves Herzuma as a biosimilar to HerceptinDrugs Herzuma (trastuzumab-pkrb) · Anti-HER2 antibody, Herceptin (trastuzumab) · Anti-HER2 antibody
2018-12-14FDA approves romiplostim for pediatric patients with immune thrombocytopeniaDrug NPLATE (romiplostim) · Megakaryocyte growth factorConditionClassical hematology
2018-10-04FDA approves emicizumab-kxwh for hemophilia A with or without factor VIII inhibitorsTrials HAVEN 3, HAVEN 4Drug HEMLIBRA (emicizumab-kxwh) · Factor IXa/Xa bridging antibodyConditionClassical hematology
2018-07-31FDA approves lusutrombopag for thrombocytopenia in adults with chronic liver diseaseTrial L-PLUS 2Drug Mulpleta (lusutrombopag) · Megakaryocyte growth factorConditionClassical hematology
2018-06-07FDA approves Mircera for anemia associated with chronic kidney disease in pediatric patients on dialysisDrug Mircera (methoxy polyethylene glycol-epoetin beta) ConditionClassical hematology
2018-06-04FDA approves first biosimilar to Neulasta to decrease the risk of infection during cancer treatmentDrugs Fulphila (pegfilgrastim-jmdb) · Granulocyte colony-stimulating factor, Neulasta (pegfilgrastim) · Granulocyte colony-stimulating factor
2018-05-21FDA approves avatrombopag for thrombocytopenia in adults with chronic liver diseaseDrug Doptelet (avatrombopag) · Megakaryocyte growth factorConditionClassical hematology
2018-05-15FDA approves Retacrit as a biosimilar to Epogen/ProcritDrug Retacrit (epoetin alfa-epbx) · Erythrocyte growth factor
2018-04-17FDA approves fostamatinib tablets for ITPTrials FIT, FITDrug TAVALISSE (fostamatinib disodium hexahydrate) · SYK inhibitorConditionClassical hematology
2018-04-10FDA approves everolimus for tuberous sclerosis complex-associated partial-onset seizuresTrial EXIST-3Drugs Afinitor Disperz (everolimus tablets for oral suspension) · MTOR inhibitor, Afinitor Disperz (oral suspension)
2017-12-21FDA approves hydroxyurea for treatment of pediatric patients with sickle cell anemiaTrial ESCORT-HUDrug Siklos (hydroxyurea) · AntimetaboliteConditionClassical hematology
2017-12-01FDA approves Ogivri as a biosimilar to HerceptinDrugs Ogivri (trastuzumab-dkst) · Anti-HER2 antibody, Herceptin (trastuzumab) · Anti-HER2 antibody
2017-11-16FDA approves emicizumab-kxwh for prevention and reduction of bleeding in patients with hemophilia A with factor VIII inhibitorsTrials HAVEN 1, HAVEN 2Drug HEMLIBRA (emicizumab-kxwh) · Factor IXa/Xa bridging antibodyConditionClassical hematology
2017-09-14FDA approves first biosimilar for cancer treatmentDrugs Mvasi (bevacizumab-awwb) · Anti-VEGFR antibody, Avastin (bevacizumab) · Anti-VEGFR antibody
2017-08-02FDA expands ibrutinib indications to chronic GVHDDrug Imbruvica (ibrutinib) · BTK inhibitorConditionOther
2017-07-11FDA grants regular approval to blinatumomab and expands indication to include Philadelphia chromosome-positive B cellDrug BLINCYTO (blinatumomab) · Anti-CD19-CD3 bispecific antibody
2017-06-23FDA approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patientsTrial APEXDrug BEVYXXA (betrixaban) · Factor Xa inhibitorConditionClassical hematology
2017-05-23FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indicationDrug KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
2017-05-10Pembrolizumab (Keytruda) 5-10-2017Drugs KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, pemetrexed · Antifolate, carboplatin · Platinum agent
2016-11-21Daratumumab (DARZALEX)Drugs DARZALEX (daratumumab) · Anti-CD38 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)
2016-10-24Pembrolizumab (KEYTRUDA) Checkpoint InhibitorDrug KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
2016-05-13Lenvatinib in combination with EverolimusDrugs Lenvima (lenvatinib) · Multikinase inhibitor, everolimus · MTOR inhibitor
2016-02-26ObinutuzumabDrugs Gazyva (obinutuzumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard
2016-02-19Palbociclib (IBRANCE Capsules)Drugs IBRANCE Capsules (palbociclib) · CDK inhibitor, fulvestrant · Estrogen receptor inhibitor
2015-12-18Pembrolizumab label updated with new clinical trial informationDrug Keytruda (pembrolizumab) · Anti-PD-1 antibody
2015-11-30ElotuzumabDrugs EMPLICITI (elotuzumab) · Anti-SLAMF7 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)
2015-11-24NecitumumabDrugs PORTRAZZA (necitumumab) · Anti-EGFR antibody, gemcitabine · Pyrimidine analog, cisplatin · Platinum agent
2015-11-20Trametinib/DabrafenibDrugs Mekinist (trametinib) · MEK inhibitor, Tafinlar (dabrafenib) · BRAF inhibitor
2015-11-20IxazomibDrugs NINLARO (ixazomib) · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)
2015-10-22Irinotecan liposome injectionDrug ONIVYDE (irinotecan liposome) · Topoisomerase I inhibitor
2015-09-30Nivolumab in combination with ipilimumabDrugs Opdivo (nivolumab) · Anti-PD-1 antibody, ipilimumab · Anti-CTLA-4 antibody
2015-08-24Eltrombopag / PromactaDrug Promacta for oral suspension (eltrombopag) · Megakaryocyte growth factor
2015-07-24Carfilzomib /KyprolisDrugs Kyprolis (carfilzomib) · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)
2015-02-23PanobinostatDrugs FARYDAK capsules (panobinostat) · HDAC inhibitor, bortezomib · Proteasome inhibitor
2015-02-03PalbociclibDrugs IBRANCE (palbociclib) · CDK inhibitor, letrozole · Aromatase inhibitor third generation
2014-12-12Ramucirumab (Cyramza)Drugs Cyramza (ramucirumab) · Anti-VEGFR antibody, docetaxel · Taxane, paclitaxel · Taxane
2014-11-14Bevacizumab solution in combination with PaclitaxelDrugs Avastin (bevacizumab solution for intravenous infusion) · Anti-VEGFR antibody, Avastin (intravenous infusion) , paclitaxel · Taxane
2014-11-05Ramucirumab in combination with paclitaxelDrugs Cyramza (ramucirumab) · Anti-VEGFR antibody, paclitaxel · Taxane
2014-08-14Bevacizumab solutionDrugs Avastin (bevacizumab solution for intravenous infusion) · Anti-VEGFR antibody, Avastin (intravenous infusion)
2014-07-23IdelalisibDrugs Zydelig tablets (idelalisib) · PI3K delta inhibitor, rituximab · Anti-CD20 antibody
2014-04-17FDA Approves OfatumumabDrugs Arzerra (ofatumumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard
2013-11-13FDA grants accelerated approval to Ibrutinib (Imbruvica)Drug IMBRUVICA (Ibrutinib) · BTK inhibitor
2013-11-01Gazyva (obinutuzumab)Drugs GAZYVA (obinutuzumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard
2013-09-30Pertuzumab InjectionDrugs PERJETA (pertuzumab) · Anti-HER2 antibody, trastuzumab · Anti-HER2 antibody, docetaxel · Taxane
2013-02-22FDA Approves Ado-Trastuzumab EmtansineDrug KADCYLA (ado-trastuzumab emtansine) · Anti-HER2 antibody-drug conjugate
2013-02-04Doxorubicin Hydrochloride Liposome (Injection)Drug doxorubicin hydrochloride liposome · Anthracycline
2012-12-10Expanded Approval forAbiraterone AcetateDrug Zytiga Tablets (abiraterone acetate) · CYP17 inhibitor
2012-08-31Enzalutamide (XTANDI Capsules)Drug XTANDI Capsules (enzalutamide) · Second-generation nonsteroidal antiandrogen
2012-08-30Everolimus for Tuberous Sclerosis Complex (TSC)Drug Afinitor Disperz (everolimus tablets for oral suspension) · MTOR inhibitor
2012-08-09vinCRIStine sulfate LIPOSOME injectionDrug Marqibo (vinCRIStine sulfate LIPOSOME) · Vinca alkaloid
2012-07-20Everolimus 2012Drugs Afinitor (everolimus) · MTOR inhibitor, exemestane · Aromatase inhibitor third generation
2012-07-09Cetuximab in Combination with Folfiri / TherascreenDrug Erbitux (cetuximab) · Anti-EGFR antibody
2012-07-07FDA approved L-glutamine powder for the treatment of sickle cell diseaseDrug Endari (L-glutamine oral powder) · Replacement therapyConditionClassical hematology
2012-06-08FDA Approves PertuzumabDrugs PERJETA (pertuzumab) · Anti-HER2 antibody, trastuzumab · Anti-HER2 antibody, docetaxel · Taxane
2011-12-06Romiplostim/EltrombopagDrugs Nplate for subcutaneous (romiplostim) · Megakaryocyte growth factor, Promacta tablets (eltrombopag) · Megakaryocyte growth factor
2011-11-18asparaginase Erwinia chrysanthemiDrug Erwinaze (asparaginase erwinia chrysanthemi) · Asparagine-specific enzyme
2010-11-15Eribulin MesylateDrug Halaven (eribulin mesylate) · Non-taxane microtubule dynamics inhibitor
2010-05-28Hexaminolevulinate HydrochlorideDrug Cysview for Intravesical Solution (hexaminolevulinate hydrochloride)
2010-02-16FDA approves a risk evaluation and mitigation strategy (REMS) to ensure the safe use of Erythropoiesis-Stimulating Agents (ESAs)"
2009-07-31Bevacizumab (Avastin) in Combination with Interferon AlfaDrugs Avastin (bevacizumab) · Anti-VEGFR antibody, interferon alfa
2009-07-17FDA Approves Cetuximab (Erbitux) and Panitumumab (Vectibix)Drug Vectibix Amgen (panitumumab) · Anti-EGFR antibody
2008-12-19Imatinib MesylateDrugs Gleevec (imatinib mesylate tablets for oral use) · Bcr-Abl inhibitor, Gleevec (oral use)
2008-08-22FDA Approves RomiplostimDrugs Nplate (romiplostim for subcutaneous) · Megakaryocyte growth factor, Nplate (subcutaneous)
2008-02-22Bevacizumab Granted Accelerated ApprovalDrugs Avastin (bevacizumab) · Anti-VEGFR antibody, paclitaxel · Taxane
2007-10-16IxabepiloneDrugs Ixempra (ixabepilone) · Non-taxane microtubule dynamics inhibitor, Ixempra (injection)
2007-09-13Raloxifene hydrochlorideDrug EVISTA (raloxifene hydrochloride) · Selective estrogen receptor modulator
2007-05-10Erythropoiesis-stimulating Agents (ESAs)Drugs Aranesp (darbepoetin alfa) · Erythrocyte growth factor, Epogen (epoetin alfa) · Erythrocyte growth factor
2007-05-01FDA Approves Dalteparin SodiumDrug Fragmin (dalteparin sodium) · Low molecular weight heparin
2006-10-19FDA approves imatinib mesylate (Gleevec) as a single agent for the treatment of multiple indicationsDrug Gleevec (imatinib mesylate) · Bcr-Abl inhibitor
2006-09-13Changes in the Neumega Package Insert to Include a Description of Ventricular Arrhythmic and Ophthalmologic Adverse Events
2006-07-14FDA approves gemcitabine (Gemzar, Eli Lilly and Company)Drugs Gemzar (gemcitabine) · Pyrimidine analog, carboplatin · Platinum agent
2006-03-03Changes in the Ontak (denileukin diftitiox) Package Insert to Include a Description of Ophthalmologic Adverse Events
2006-03-01Erbitux (ceuximab) Approved for Use in Combination with Radiation TherapyDrug Erbitux (cetuximab) · Anti-EGFR antibody