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This page references recently approved drugs and novel therapies from the FDA. Click below for the press release on each drug, which will provide the relevant clinical information on indication, contraindications, dosing, and safety. In sharing this information, ASPET does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described. 


DateNameDescriptionPress Release
December 18, 2020 OsimertinibFDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutationsMore Info
December 18, 2020relugolixFDA approves relugolix for advanced prostate cancerMore Info
December 18, 2020SelinexorFDA approves selinexor for refractory or relapsed multiple myelomaMore Info
December 16, 2020margetuximab-cmkbFDA approves margetuximab for metastatic HER2-positive breast cancerMore Info
December 1, 2020Gallium 68 PSMA-11FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate CancerMore Info
December 1, 2020pralsetinibFDA approves pralsetinib for RET-altered thyroid cancersMore Info
November 25, 2020naxitamabFDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow More Info
November 23, 2020lumasiranFDA Approves First Drug to Treat Rare Metabolic Disorder More Info
November 20, 2020lonafarnibFDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid LaminopathiesMore Info
November 13, 2020pembrolizumabFDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancerMore Info
October 22, 2020remdesivirFDA Approves First Treatment for COVID-19More Info
October 16, 2020venetoclaxFDA grants regular approval to venetoclax in combination for untreated acute myeloid leukemiaMore Info
October 14, 2020atoltivimab, maftivimab, and odesivimab-ebgnFDA Approves First Treatment for Ebola VirusMore Info
October 14, 2020pembrolizumabFDA extends approval of pembrolizumab for classical Hodgkin lymphomaMore Info
October 2, 2020nivolumab; ipilimumabFDA approves nivolumab and ipilimumab for unresectable malignant pleural mesotheliomaMore Info
September 4, 2020pralsetinibFDA approves pralsetinib for lung cancer with RET gene fusionsMore Info
September 1, 2020onuregFDA approves Onureg (azacitidine tablets) for acute myeloid leukemiaMore Info
August 20, 2020carfilzomib and daratumumabFDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma More Info
August 17, 2020satralizumab-mwgeFDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal CordMore Info
August 12, 2020viltolarsenFDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation More Info
August 7, 2020oliceridineFDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical SettingsMore Info
August 7, 2020risdiplamFDA Approves Oral Treatment for Spinal Muscular AtrophyMore Info
August 5, 2020Belantamab Mafodotin-blmf FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myelomaMore Info
July 31, 2020Tafasitamab-cxix FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphomaMore Info
July 30, 2020AtezolizumabnFDA approves atezolizumab for BRAF V600 unresectable or metastatic melanomaMore Info
July 24, 2020Brexucabtagene Autoleucel FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCLMore Info
July 2, 2020Fostemsavir

FDA Approves New HIV Treatment for Patients With Limited Treatment Options

More Info
June 22, 2020SelinexorFDA Grants Accelerated Approval to Selinexor for Relapsed/Refractory Diffuse Large B-Cell Lymphoma More Info

June 18, 2020

Tazemetostat FDA granted accelerated approval to tazemetostat for follicular lymphoma More Info
June 16, 2020Gemtuzumab OzogamicinFDA approves gemtuzumab ozogamicin for CD33-positive AML in pediatric patientsMore Info
June 16, 2020PembrolizumabFDA approves pembrolizumab for adults and children with TMB-H solid tumorsMore Info
June 15, 2020Lurbinectedin FDA approves lurbinectedin to treat metastatic small cell lung cancerMore Info
June 11, 2020Inebilizumab-cdon FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal CordMore Info
May 26, 2020Artesunate FDA Approves Only Drug in U.S. to Treat Severe MalariaMore Info
May 15, 2020RipretinibFDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal TumorsMore Info
May 8, 2020Selpercatinib FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion More Info
May 6, 2020CapmatinibFDA Approves First Targeted Therapy to Treat Aggressive Form of Lung CancerMore Info

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