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Globus Medical Receives the CE Mark for Excelsius3D

Shots: Globus Medical has reported the CE Mark approval for Excelsius3D intelligent 3-in-1 imaging system, expanding the company’s Excelsius Ecosystem & enhancing the capabilities of its ExcelsiusGPS robotic navigation system Excelsius3D combines 3D cone-beam CT, 2D fluoroscopy & digital radiography in one mobile intraoperative platform, integrating with ExcelsiusGPS for seamless imaging & robotic navigation to…
September 4, 2026

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Cipla Partners with Qilu Pharmaceutical to Commercialize QL2107 (Biosimilar, Keytruda) in the US

Shots: Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, has entered into a strategic partnership with Qilu Pharmaceutical for the exclusive licensing & supply of QL2107, a biosimilar version of Keytruda (pembrolizumab), for the US As per the deal, Qilu will handle product development, regulatory registration & supply, while Cipla USA will commercialize the asset across the…
September 4, 2026

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United Imaging Healthcare Receives CE Mark for Dual Wide-Coverage CT Systems

Shots: United Imaging Healthcare has received CE Mark certification for uCT SiriuX and uCT SiriuX Ultrix, described as the world’s first dual wide-coverage CT family, enabling commercial availability across the EU Built on a Twin-Ring Gantry architecture, the systems combine dual-wide 16cm Ultrix detectors with 2 liquid-metal-bearing X-ray tubes to support synchronized whole-organ dynamic imaging,…
September 4, 2026

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Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease
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Biogen and Eisai Report NMPA Approval of Leqembi (SC) as an Initiation Dose for Early Alzheimer’s Disease

Shots: The NMPA has approved Leqembi (SC autoinjector/SC-AI) as an initiation dose administered as 500mg given QW as two consecutive 250mg injections, each delivered in ~15secs, for the treatment of early Alzheimer's disease  Approval was supported by 18mos. P-III Clarity AD data & multiple SC administration sub-studies (incl. Chinese cohort), with SC-AI 500mg (QW) showing…
September 3, 2026

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Heartvue.ai and Innolitics Receive FDA 510(k) Clearance for Heartvue.Proton

Shots: The US FDA has granted 510(k) clearance (K260811) to Heartvue.Proton, a machine learning-powered platform for viewing, post-processing & quantitative evaluation of cardiovascular MR images  The platform automates 2D linear dimensions, ventricular volumes & ejection fraction, and blood flow quantification, while keeping results under physician review. It integrates with hospital PACS & EHR systems to…
September 3, 2026

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GSK Licenses HUTCHMED’s HMPL-A830 Outside Greater China in a ~$1.295B Deal

Shots: HUTCHMED has granted GSK worldwide rights to develop & commercialize HMPL-A830 (excl. Mainland China, Hong Kong, Macau and Taiwan), with clinical development initially focussing on colorectal, pancreatic & lung cancer indications As per the deal, HUTCHMED will be responsible for the global P-I program, (expected to start in H2’26), while GSK subsidiary will handle…
September 3, 2026

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