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Pharma Now Editorial Team
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FDA Gains Full Approval for Veklury Following EUA-to-Approval Transition in COVID-19 Treatment
FDA's full approval of Veklury sets a precedent for EUA-to-approval transitions, with direct implications for manufacturers in accelerated regulatory frameworks.
Pharma Now Editorial Team
FDA Authorizes Gohibic Vilobelimab Injection for Hospitalized COVID-19 Adults on Mechanical Ventilation
FDA issues EUA for Gohibic (vilobelimab) IV injection in hospitalized COVID-19 adults on mechanical ventilation, setting sterile injectable and labeling benchmarks.
Pharma Now Editorial Team
FDA Grants Remdesivir Emergency Use Authorization for Severe COVID-19 in Hospitalized Patients
FDA's 2020 remdesivir EUA offers a durable framework reference for manufacturers structuring regulatory dossiers under emergency authorization pathways.
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MSP Vaccine Company Gains FDA Approval Update for VAXELIS Hexavalent Combination Vaccine in March 2026
FDA issued a March 2026 approval letter for MSP Vaccine Company's VAXELIS, the hexavalent pediatric combination vaccine licensed under STN 125563.
Pharma Now Editorial Team
