FDA approves nivolumab with ipilimumab for colorectal cancer
On April 8, 2025, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for adult and pediatric patients 12 years …
U.S. Food and Drug Administration Approves Opdivo® …
Apr 11, 2025 · Based on the Phase 3 CheckMate-9DW trial, Opdivo plus Yervoy demonstrated a statistically significant overall survival benefit compared to investigator’s choice of lenvatinib or …
Opdivo (nivolumab) FDA Approval History - Drugs.com
Apr 14, 2025 · FDA approval history for Opdivo (nivolumab) used to treat Melanoma, Metastatic, Non Small Cell Lung Cancer, Renal Cell Carcinoma, Hodgkin's Lymphoma, Head and Neck …
FDA Approves Nivolumab With Ipilimumab for Unresectable or …
Apr 25, 2025 · On April 8, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor nivolumab (Opdivo) with the CTLA-4 inhibitor ipilimumab (Yervoy) for adult and …
FDA Approves OPDIVO® Plus YERVOY® for Unresectable or …
Apr 24, 2025 · The present FDA approval is based on CheckMate 8HW, which is an ongoing Phase III, multinational, open-label, randomized trial evaluating Nivolumab plus Ipilimumab as …
U.S. Food and Drug Administration (FDA) Grants Priority Review to ...
Dec 11, 2025 · In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of …
Bristol Myers Squibb’s Opdivo-Plus-Chemotherapy Regimen for …
6 days ago · In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of …
FDA Approves Opdivo + Yervoy for CRC – Medthority
Apr 10, 2025 · This approval is based on the CheckMate-8HW trial, which is the largest Phase III trial (n=839) of immunotherapy in patients with MSI-H/dMMR mCRC, evaluating Opdivo plus …
FDA Approves Nivolumab/Ipilimumab Combo in MSI-H/dMMR …
Apr 8, 2025 · The FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line therapy for adult and pediatric patients (≥12 years) with microsatellite instability–high (MSI-H) or …
FDA Approves Opdivo / Nivolumab Plus Yervoy / Ipilimumab …
Date: April 8, 2025 On April 8, 2025, the FDA granted regular approval to nivolumab (Opdivo) combined with ipilimumab (Yervoy) for first-line treatment of unresectable or metastatic MSI-H …