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DIOSynVax is developing its COVID-19 vaccine using computer modeling to identify the virus’ genetic code in the hopes of producing a vaccine that is specific to developing antibodies against SARS-CoV-2. Read More
Novavax has announced that it will start a late-stage clinical trial of its investigational COVID-19 vaccine in the U.S. by the end of November. Read More
The FDA will not make COVID-19 vaccine developers go through pre-approval inspections for an Emergency Use Authorization (EUA), but companies will have to submit detailed manufacturing data and meet certain other requirements, said a senior official in the Center for Biologics Evaluation and Research (CBER). Read More
Pfizer CEO Albert Bourla announced Tuesday that the company won’t have the necessary phase 3 trial data required to submit its COVID-19 vaccine candidate for Emergency Use Authorization (EUA) this month, despite previous projections. Read More
The FDA has had to push back its review of Spectrum Pharmaceuticals’ biologics license application (BLA) for Rolontis (eflapegrastim) due to COVID-19 travel restrictions. Read More