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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.
Pharma Now Editorial Team
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
