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General-Purpose AI Outperforms FDA-Cleared Clinical Tools
New study shows general-purpose AI is beating FDA-cleared clinical tools. Explore the growing validation gap and what it means for the future of healthcare.
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FDA Reviews Regeneron’s Cemdisiran for Myasthenia Gravis
The FDA is reviewing Regeneron's cemdisiran for generalized myasthenia gravis. Learn how this RNAi therapy targets the complement system for gMG treatment.
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Infigratinib Shows Promise for Advanced Gastric Cancer
A Phase 2 trial reveals that infigratinib offers promising results for patients with FGFR2-amplified advanced gastric or GEJ adenocarcinoma.
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Indian Pharma Stocks Surge on US FDA Cancer Drug Demand
Major Indian pharma stocks rally as the US FDA seeks to address critical cancer drug shortages by engaging top manufacturers for increased supply.
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VahatiCor Launches U.S. Trial for CMD A-FLUX Reducer System
VahatiCor has enrolled its first U.S. patient in a clinical trial for the A-FLUX Reducer System, a novel device targeting Coronary Microvascular Dysfunction.
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FDA Launches New Pilot to Accelerate Drug Development
The FDA has launched a new pilot program to accelerate drug testing and innovation in response to the growing global competition in the biotech sector.
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Pfizer Lung Cancer Drug Trial Fails to Meet Primary Goal
Pfizer’s experimental lung cancer drug missed its primary endpoint in a Phase 3 trial. Discover what this setback means for oncology and patient treatment.
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New Clinical Trial Reforms Target Global Security Risks
Health officials are implementing strict clinical trial reforms to protect research integrity and national security from growing foreign threats.
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FDA Launches New Strategy to Fast-Track Drug Development
The FDA is launching new strategies to accelerate drug development, focusing on improved trial designs and real-world evidence to fast-track innovation.
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FDA Updates Master Protocol Guidance for Basket Trials
The FDA has updated its master protocol guidance to include new instructions on basket trials, aiming to accelerate the development of precision medicines.