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.
You may also be interested in...
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.
Data on medRxiv showed a 90% improvement in likelihood of need for mechanical ventilation in the intent-to-treat population. The company plans a filing in Q2.
After decades without an approval pathway for excipients, FDA pilot program paves the way for innovation.