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Results For "CE-Mark"

112 News Found

Epigenica expands into Japan via PrimeTech partnership
News | March 20, 2026

Epigenica expands into Japan via PrimeTech partnership

The move opens Japan’s advanced life science market to Epigenica’s high-throughput epigenetic profiling kits


FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer
Drug Approval | February 21, 2026

FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer

The NDA filing is supported by results from the phase III evERA Breast Cancer study


GSK India crosses Rs. 1,000 crore mark, key portfolios drive 8.1% topline growth
News | February 10, 2026

GSK India crosses Rs. 1,000 crore mark, key portfolios drive 8.1% topline growth

Launched in August 2025, GSK India’s Oncology business is rapidly gaining momentum


Merck scores FDA nod for TGT drug Pimicotinib, promising new hope for patients
Drug Approval | January 14, 2026

Merck scores FDA nod for TGT drug Pimicotinib, promising new hope for patients

The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes


Diabeloop bags FDA nod for DBLG2, opens US market for automated insulin delivery
Drug Approval | January 12, 2026

Diabeloop bags FDA nod for DBLG2, opens US market for automated insulin delivery

The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market


Lupin and Gan & Lee enter exclusive licensing deal for novel GLP-1 receptor agonist
News | December 29, 2025

Lupin and Gan & Lee enter exclusive licensing deal for novel GLP-1 receptor agonist

Lupin has bolstered its diabetes and obesity portfolios by securing an agreement for Bofanglutide, a GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals


Abbott’s Volt PFA System gets FDA nod
News | December 24, 2025

Abbott’s Volt PFA System gets FDA nod

AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life


Abbott wins FDA & CE nod for groundbreaking premature infant heart device
Medical Device | December 22, 2025

Abbott wins FDA & CE nod for groundbreaking premature infant heart device

The system is intended for some of the tiniest patients—premature infants weighing as little as two pounds