BRIEF-Krystal Biotech Announces FDA’s 3-Month Extension Of BLA PDUFA Date, Regulatory Update For B-VEC

Reuters

2023/01/09

Jan 9 (Reuters) - Krystal Biotech Inc :

* KRYSTAL BIOTECH ANNOUNCES FDA’S 3-MONTH EXTENSION OF BLA PDUFA DATE AND REGULATORY UPDATE FOR B-VEC TO TREAT PATIENTS WITH DYSTROPHIC EPIDERMOLYSIS BULLOSA

* KRYSTAL BIOTECH INC - PDUFA DATE HAS BEEN REVISED TO MAY 19, 2023, AND PROPOSED LABELING DISCUSSIONS TO NO LATER THAN APRIL 20, 2023

Source text for Eikon: Further company coverage:

((Reuters.Briefs@thomsonreuters.com;))

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