Biocartis Reports the US FDA’s Approval of Idylla CDx MSI Test to Identify MSI-H Colorectal Cancer Patients

Shots:The US FDA has approved the PMA application for Idylla CDx MSI Test, a cartridge-based, fully automated “sample-to-result” companion diagnostic, with US launch anticipated soon & availability in other non-US markets to followThe Idylla CDx MSI Test helps identify MSI-H colorectal cancer pts eligible for Opdivo (nivolumab) alone or with Yervoy (ipilimumab), as…

ByRidhi RastogiSeptember 17, 2025

TOP 20

Top 20 Oncology Companies of 2025

Shots: ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…

ByPrince GiriSeptember 3, 2025

NEWS

Henlius and Sandoz Enter a Global Collaboration Agreement to Commercialize HLX13 (Biosimilar, Yervoy)

Shots:Henlius has granted Sandoz exclusive rights of the HLX13, a biosimilar version of Yervoy (ipilimumab), which is being assessed in a Henlius-led P-I/III trial for inoperable HCC, targeting enrollment of 656 ptsAs per the deal, Sandoz will register & market HLX13 in Australia, Canada, EU, Japan, & the US in exchange for milestone-based…

ByRidhi RastogiApril 30, 2025

NEWS

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 adultsApproval 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

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

Shots:The US FDA has approved Opdivo + Yervoy for 1L treatment of MSI-H/dMMR unresectable mCRC pts (≥12yrs.) based on P-III (CheckMate-8HW) study assessing Opdivo + Yervoy vs Opdivo alone or CT in 839 pts (Approved before PDUFA: Jun 23, 2025)Regimen vs Opdivo monotx. showed 38% PFS (mPFS: not reached (NR) vs 39.3mos) in…

ByRidhi RastogiApril 9, 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 OpdivoBMS’ Opdivo gives tough competition to other drugs in the…

BySenior EditorDecember 22, 2022

VIEWPOINTS

PharmaShots Interview: BMS’ Dr. Ian Waxman Shares Insights on the Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC

In an interview with PharmaShots, Dr. Ian Waxman, MD, Development Lead, Gastrointestinal Cancer at BMS shared his views on the EC's approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for the Treatment of dMMR or MSI-H mCRCShots:The approval is based on P-II CheckMate -142 study evaluating Opdivo + Yervoy in patients with dMMR or MSI-H mCRC whose disease had…

BySenior EditorSeptember 28, 2021

Biocartis Reports the US FDA’s Approval of Idylla CDx MSI Test to Identify MSI-H Colorectal Cancer Patients

Top 20 Oncology Companies of 2025

Henlius and Sandoz Enter a Global Collaboration Agreement to Commercialize HLX13 (Biosimilar, Yervoy)

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

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

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

Top Performing Drug of 2021 – Opdivo (December Edition)

PharmaShots Interview: BMS’ Dr. Ian Waxman Shares Insights on the Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC

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