Humanigen Aims For New EUA Request After FDA Turns Down Lenzilumab
Executive Summary
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...
Humanigen Isn’t Throwing In The Towel On Lenzilumab For COVID-19 Just Yet
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.
Lenzilumab & Evusheld Make It Onto EU List Of ‘Most Promising’ COVID-19 Treatments
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.
COVID-19-Induced Actemra Shortage Causes Headaches For CAR-T Centers
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.