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Top Clinical Trials Arena News
FDA · United StatesThe Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs.
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FDA to streamline approvals of generic biologic drugs
86% Center coverage: 36 sources
Stock Markets · United StatesSarepta Therapeutics attributed the Phase 3 failure to the Covid-19 pandemic, during which many patients missed multiple doses of its Duchenne muscular dystrophy therapies. The company plans to discuss with the FDA traditional regulatory approvals based on the totality of data that includes real world evidence from the years these drugs have been commercially available under accelerated approvals. The post Despite Phase 3 Failure, Sarepta Still …See the Story
Despite Phase 3 Failure, Sarepta Still Sees Path for Muscle Disease Drugs to Secure Full FDA Approval
67% Center coverage: 3 sources
Saint-Herblain · Saint-HerblainImmune response successfully improved with second generation vaccine candidate Saint-Herblain (France), November 4, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced positive results of its Phase 1 clinical trial investigating the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV). The randomized controlled Phase 1 trial, VLA160…See the Story
Valneva Reports Positive Results for Phase 1 Trial of Second-Generation Zika Vaccine Candidate
Coverage: 2 sources
