Moderna pulls Combo BLA
Moderna Inc. announced that in consultation with the FDA the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/Covid combination vaccine candidate for adults aged 50 years and older.
Moderna Inc. announced that in consultation with the FDA the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/Covid combination vaccine candidate for adults aged 50 years and older.
The Company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase III trial of its investigational seasonal influenza vaccine, mRNA-1010, are available. Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer.
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