Humanigen Aims For New EUA Request After FDA Turns Down Lenzilumab
The company plans to make a new EUA request prior to filing a BLA, but does not yet have a specific timeline. Meanwhile, it has been preparing for the drug’s distribution as a COVID-19 treatment.
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The company is assessing a potential path forward in COVID-19 for the drug and is in talks with platform study groups after a Phase III study did not show statistical significance, but still showed activity.
Two products that were on the European Commission’s original list of the “top five” COVID-19 candidate therapeutics in development have been dropped from the latest “top 10” portfolio.
While some cancer centers report sufficient stocks of the drug, they have already been turning to potential alternatives due to supply issues that could last for weeks or months.