FDA’s new and supplemental approvals in February

FDA approved six new therapies in February, including one that received a rare pediatric disease priority review voucher at a time when the program’s fate is in limbo.

The agency approved Gomekli mirdametinib from Springworks Therapeutics Inc. (NASDAQ:SWTX) to treat pediatric and adult patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that can’t be fully resected. Springworks has not said whether it plans to use or sell the priority review voucher it received with the approval. Given the uncertainty in reauthorization of the voucher program, the market value of the vouchers has risen to $150 million in recent sales. ...