INmune Bio submits final pre-marketing authorization application package to UK MHRA for Ebstrocel

INmune Bio submitted its final pre-marketing authorization application package to the UK MHRA for Ebstrocel for recessive dystrophic epidermolysis bullosa. The company expects full MAA submission in early February 2027 with potential UK approval in mid-2027, and has engaged US regulatory advisors to prepare a Type B meeting request to the FDA.

Detected & updated continuously · Source: Nebula