Rare Pediatric Disease Priority Review Voucher

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FDA approves innovative gene therapy to treat pediatric ...

(1 months ago) The FDA also awarded the manufacturer a rare pediatric disease priority review voucher, under a program intended to encourage the development of new drugs and biological products for the ...

https://www.fda.gov/news-events/press-announcements/fda-approves-innovative-gene-therapy-treat-pediatric-patients-spinal-muscular-atrophy-rare-disease

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FDA Approves First Treatment for Ebola Virus | FDA

(1 days ago) Today, the FDA approved Inmazeb, a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-ebola-virus

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Soligenix Granted Pediatric Investigational Plan Waiver ...

(23 days ago) CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and ...

https://www.prnewswire.com/news-releases/soligenix-granted-pediatric-investigational-plan-waiver-for-hybryte-in-ctcl-in-the-united-kingdom-301418320.html

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