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NEWS

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 follow The Idylla CDx MSI Test helps identify MSI-H colorectal cancer pts eligible for Opdivo (nivolumab) alone or with Yervoy (ipilimumab), as…
September 17, 2025

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Innovent
NEWS

Innovent Reports the NMPA’s NDA Acceptance & Priority Review of Neoadjuvant Ipilimumab + Sintilimab for Colon Cancer

Shots: China’s NMPA has accepted NDA & granted priority review to ipilimumab (IBI310) + sintilimab as neoadj. treatment of operable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer Submission was based on P-III (NeoShot) trial assessing safety & efficacy of ipilimumab + sintilimab vs direct radical surgery in MSI-H/dMMR colon cancer pts …
February 24, 2025

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New Drug Designations - October 2023
INSIGHTS+

New Drug Designations – October 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA and the EMA. This month’s report includes 2 biological drugs, 12 small molecules, 10 cell and gene therapies, 2 vaccines, 1 peptide, 1 exosome-based therapy and 3 devices  HuidaGene Therapeutics’ HG204 CRISPR RNA-editing therapy, focused on the treatment of MECP2 duplication…
November 20, 2023

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Viewpoints_Dr. Ian Waxman
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 mCRC Shots: The approval is based on P-II CheckMate -142 study evaluating Opdivo + Yervoy in patients with dMMR or MSI-H mCRC whose disease had…
September 28, 2021

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