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Innovent
Innovent’s Tabosun (Ipilimumab N01) Receives the NMPA approval for MSI-H/dMMR Resectable Colon Cancer
Shots: The NMPA has approved Innovent's Tabosun (ipilimumab N01 injection or IBI310) + sintilimab for the neoadj. treatment of stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer Approval was based on the P-III (NeoShot) trial assessing ipilimumab N01 + sintilimab as neoadj. therapy in pts with MSI-H/dMMR colon cancer Trial met…
December 26, 2025
Gilead Sciences to Acquire Repare Therapeutics’ Polθ ATPase Inhibitor RP-3467 for ~$30M
Shots: Repare Therapeutics has entered into a definitive asset purchase agreement with Gilead Sciences for the acquisition of Repare's RP-3467, a polymerase theta (Polθ) ATPase inhibitor, strengthening Gilead’s precision oncology pipeline Under the Agreement, Repare will receive up to $30M in total consideration, including $25M upfront (subject to customary adjustments) and an additional $5M upon…
December 25, 2025
Agios Reports the US FDA Approval of Aqvesme for Anemia in Alpha or Beta Thalassemia
Shots: The US FDA has approved Agios’ Aqvesme (mitapivat) for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies (n=452), which met all 1EPs and 2EPs, demonstrating significant improvements in hemoglobin, fatigue, and reductions in transfusion burden vs PBO Aqvesme…
December 25, 2025
SN BioScience Receives US FDA ODD for SNB-101 in Gastric Cancer
Shots: US FDA has granted Orphan Drug Designation (ODD) to SN BioScience’s SNB-101 for the treatment of gastric cancer, including gastroesophageal junction cancer SNB-101 is currently under P-Ib/II development for small cell lung cancer and is being evaluated across multiple solid tumor indications in Korea, Europe and US SNB-101 is a polymer nanoparticle formulation of…
December 25, 2025
The US FDA Approves Edwards Lifesciences’ SAPIEN M3 Mitral Valve Replacement System for Mitral Regurgitation
Shots: The US FDA has approved Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement (TMVR) system as the transseptal transcatheter therapy for the treatment of symptomatic moderate-to-severe or severe mitral regurgitation (MR) SAPIEN M3 is indicated for pts unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy, including those with mitral valve dysfunction associated with…
December 25, 2025
Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)
Shots: Zydus Lifesciences has entered into a strategic licensing, supply & commercialization agreement with Bioeq for Nufymco (ranibizumab), an interchangeable biosimilar to Lucentis, for the US market, marking an expansion of Zydus’ US biosimilar portfolio Under the agreement, Bioeq will handle development, manufacturing, registration & supply of the finished product while Zydus will lead US…
December 25, 2025
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