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
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
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
2019-09-17Simultaneous review decisions for pembrolizumab plus lenvatinib in Australia, Canada and USDrugs KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, LENVIMA (lenvatinib) · Multikinase inhibitor
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
2016-10-24Pembrolizumab (KEYTRUDA) Checkpoint InhibitorDrug KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
2015-12-18Pembrolizumab label updated with new clinical trial informationDrug Keytruda (pembrolizumab) · Anti-PD-1 antibody
2015-09-30Nivolumab in combination with ipilimumabDrugs Opdivo (nivolumab) · Anti-PD-1 antibody, ipilimumab · Anti-CTLA-4 antibody