Feb 02, 2026
Summary Approximately 1,600 prevalent cases were diagnosed across the 7MM in 2025, underscoring the condition's rarity and the concentration of patients at specialized metabolic and nephrology centers. Treatment is limited to long-standing cysteamine products, PROCYSBI, CYSTAGON/NICYSTAGON (cysteamine bitart...
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Jan 30, 2026
Summary The European Commission granted marketing authorization for DAWNZERA (donidalorsen) on January 21, 2026. Developed by Ionis Pharmaceuticals and Otsuka Pharmaceutical, it is the first and only RNA-targeted therapy approved in the EU for the prevention of hereditary angioedema (HAE). Approval ...
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Jan 29, 2026
Seno Medical’s Next-Generation Imagio® Imaging System Obtained European Union (EU) Medical Device Regulation (MDR) CE Mark Certification On January 26, 2026, Seno Medical received CE Mark certification for its next-generation Imagio® Imaging System, Model 9100, confirming that the device met the stringent ...
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Jan 28, 2026
Varicose veins, enlarged, tortuous veins most commonly occurring in the lower extremities, impact millions worldwide, causing discomfort, cosmetic concerns, and, in severe cases, complications such as venous insufficiency or ulcers. While traditional varicose vein treatments such as compression stockings and surgic...
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Jan 27, 2026
Sanofi’s Amlitelimab Demonstrates Promise in Atopic Dermatitis Following the positive findings from the COAST 1 trial (NCT06130566) reported in September 2025, two additional global Phase 3 studies, SHORE (NCT06224348) and COAST 2 (NCT06181435), have further strengthened the clinical evidence supporting amliteli...
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Jan 26, 2026
Summary Sobi has received European Commission approval for ASPAVELI (pegcetacoplan) to treat C3G and primary IC-MPGN, two rare, progressive kidney diseases. The approval follows a positive CHMP opinion (December 2025) and marks the first approved treatment for primary IC-MPGN and the first for both C3G...
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Jan 23, 2026
The 44th Annual J.P. Morgan Healthcare Conference, held January 12-15, 2026, in San Francisco, revealed a pharmaceutical sector at an inflection point. With major blockbusters facing patent expirations, industry leaders such as Eli Lilly, Novo Nordisk, Bristol Myers Squibb, AbbVie, Bayer, Pfizer, Novartis, Roche, M...
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Jan 22, 2026
Sonomotion Announced FDA Clearance for its Break Wave™ Lithotripsy Device for Treatment of Kidney Stones On January 21, 2026, SonoMotion, a venture-backed medical device company focused on developing non-invasive solutions for kidney stone treatment, announced that it had received U.S. Food and Drug Admini...
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Jan 21, 2026
In the intricate world of modern clinical practice, the ability to safely and reliably access a patient's circulatory system is perhaps the most fundamental requirement of acute and chronic care. Vascular Access Devices (VADs), ranging from simple peripheral catheters to complex implanted ports, serve as the "highw...
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Jan 20, 2026
Nxera Pharma Reports Positive Phase 3 Trial Results for Daridorexant in South Korea Nxera Pharma announced top-line results from its pivotal Phase 3 clinical trial of daridorexant in South Korea, showing that the study successfully met both primary and secondary endpoints in adult and elderly patients with insom...
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