The US FDA Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma (HCC)

Shots: The US FDA has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adults Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg, Q4W) vs lenvatinib/sorafenib in 668 pts with advanced HCC who had not received prior systemic therapy.…

ByRidhi RastogiApril 14, 2025

News

The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

Shots: The EC has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adult pts in 30 EEA states; sBLA under the US FDA’s priority review (PDUFA: Apr 21, 2025) Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg,…

ByRidhi RastogiMarch 10, 2025

INSIGHTS+

Top Performing Drug of 2021 – Opdivo (December Edition)

Active Ingredient: Nivolumab Strength: 40 mg/4 mL, 100 mg/10 mL, & 240 mg/24 mL solution in a single-dose vial Dosage Form: Injection Mechanism of Action: Programmed cell death-1 receptor antagonists (PD-1) First Approval: US (22 Dec 2014), EU (19 Jun 2015)  Revenue Analysis of Opdivo BMS’ Opdivo gives tough competition to other drugs in the…

BySenior EditorDecember 22, 2022

VIEWPOINTS

PharmaShots Interview: Mahesh Karande, CEO of Omega Therapeutics Shares Insights from the Preclinical Data Presented at the AACR 2022

Shots: Mahesh talked about the data presented on its lead candidate in hepatocellular carcinoma at the AACR 2022 Mahesh also spoke about Omega’s drug-development platform that identifies and targets specific and unique DNA sequences of regulatory elements The interview gives a profound grip on Omega’s development strategies to use mRNA therapeutics as a new class…

BySenior EditorJuly 19, 2022

The US FDA Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma (HCC)

The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

Top Performing Drug of 2021 – Opdivo (December Edition)

PharmaShots Interview: Mahesh Karande, CEO of Omega Therapeutics Shares Insights from the Preclinical Data Presented at the AACR 2022

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The US FDA Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma (HCC)

The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

Top Performing Drug of 2021 – Opdivo (December Edition)

PharmaShots Interview: Mahesh Karande, CEO of Omega Therapeutics Shares Insights from the Preclinical Data Presented at the AACR 2022

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