Stryker’s Incompass Total Ankle Wins FDA Clearance
Stryker FDA-cleared InCompass Ankle; protein degrader partnerships drive innovation.
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Category: Regulatory
Hereditary Angioedema Drug From CSL Gains German Backing
Hereditary angioedema therapy by CSL Behring gains positive nod in Germany.
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FDA Import Ban Disrupts Olympus’ US Medical Supply
FDA import ban issued on Olympus medical devices from Japan for quality violations.
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FDA Probes Elevidys Deaths, Stirring Regulatory and Market Uncertainty
FDA investigates Elevidys deaths, raising new safety and regulatory questions for gene therapies.
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Neuron23’s NEU-411 Trial Shifts the Parkinson’s Paradigm Toward Precision
Neuron23 advances NEU-411 into Phase II Parkinson’s trial, driven by biomarker-based strategies and strong investor support.
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