COVID-19 Vaccine Regulatory Strategy Evolving With The Pandemic
AstraZeneca and Novavax have not filed EUAs for their vaccines, and they never might. The pathway remains viable in the short-term, but as BLAs are approved and supplies are no longer short, the window may close.
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Keeping Track: First COVID Vaccine BLA Kicks Off; Oncology Submissions From Hutchmed, Takeda And Shorla
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
BIO chief calls US Defense Production Act ‘misguided’ as India seeks more COVID vaccines; America will donate AstraZeneca vaccine – just as soon as the FDA determines it was adequately manufactured.
Based on the historical time between Phase III results and filing announcements, AstraZeneca is way behind the pace. The firm will soon have waited longer to submit its EUA to the US FDA than the three already-authorized products waited combined.