Skip to content
Latest News
May 2, 2025
Novo Nordisk ($NVO) announced that the FDA has accepted its application for an oral version of Wegovy (semaglutide). While not specifically stated, the Q4 2025 PDUFA date implies a Priority Review Voucher was used for this submission.
April 29, 2025
Abeona Therapeutics Inc ($ABEO) received FDA approval today for Zevaskyn (prademagene zamikeracel) for wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa. With this approval they received a Rare Pediatric Disease Priority Review Voucher.
April 17, 2025
Regeneron Pharmaceuticals Inc $REGN redeems a priority review voucher for a supplemental Biologics License Application for EYLEA HD (aflibercept). The sBLA seeks approval for EYLEA HD for both the treatment of macular edema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications.
February 27, 2025
Zevra Therapeutics, Inc. $ZVRA announced today that they have entered into an agreement with an undisclosed buyer to sell their priority review voucher for $150 million. The PRV was awarded to Zevra in September 2024 in conjunction with the approval of Miplyffa.
February 14, 2025
Bavarian Nordic A/S $BAVA.CO was issued a Tropical Disease PRV following FDA approval of Vimkunya (chikungunya vaccine, recombinant) for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older.
February 12, 2025
U.S Congressman Michael McCaul (representing the 10th District of Texas) reintroduces the Give Kids a Chance Act that seeks to extend the FDA Rare Pediatric Disease Priority Review Voucher program to September 2029.
February 11, 2025
SpringWorks Therapeutics, Inc. $SWTX was issued a Rare Pediatric Disease PRV following FDA approval of Gomekli (mirdametinib) for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
January 31, 2025
Novartis $NVS stated at their Q4 earnings that they intend to use a PRV with their filing for remibrutinib in chronic spontaneous urticaria (CSU).
Want to print your doc?
This is not the way.
This is not the way.
Try clicking the ⋯ next to your doc name or using a keyboard shortcut (
CtrlP
) instead.