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Sunday, 04/25/2021 2:47:19 AM

Sunday, April 25, 2021 2:47:19 AM

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PDUFA Dates

https://www.benzinga.com/general/biotech/21/04/20779951/the-week-ahead-in-biotech-april-25-may-1-fda-decisions-for-sol-gel-protalix-bio-ardelyx

The Food and Drug Administration is scheduled to announce its verdict on Sol-Gel Technologies Ltd.'s
SLGL 0.21%
new drug application for Epsolay in the treatment of inflammatory lesions of rosacea. The PDUFA date, or the deadline for announcing the decision, is Monday.

The FDA will also rule on Protalix BioTherapeutics, Inc.'s
PLX 4.64%
biologic license application for pegunigalsidase alfa in Fabry disease. The PDUFA date is set for Tuesday.
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