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Shionogi & Co., Ltd. announced the Taiwan Food and Drug Administration's acceptance of a new drug application for ensitrelvir fumaric acid, an oral antiviral for COVID-19. This marks a significant step in expanding treatment options against the virus, especially considering the estimated 1.7 million COVID-19 patients in Taiwan annually.

Ildong Pharmaceutical will resubmit its application for Ensitrelvir, an oral antiviral drug for COVID-19, after strengthening clinical data.

The FDA is creating a more accessible regulatory environment for cell and gene therapy companies, according to executives at BioFuture 2024.

Shionogi's ensitrelvir significantly reduced symptomatic SARS-CoV-2 infection in individuals exposed to household contacts with COVID-19, meeting the primary endpoint in a Phase 3 trial.