Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...

Are Priority Review Vouchers The Answer To Incentivize Drug Development? Not So Fast. Pranav Aurora Morgan Romine Gregory Daniel June 15, 2016 10.1377/forefront.20160615.055372 Add to favorites ...

Based on positive Phase II TRANSCEND FL data showing a 95.5% overall response rate, the FDA has accepted Bristol Myers Squibb’s sBLA for Breyanzi in relapsed or refractory MZL with a PDUFA date set ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

The Priority Review indicates a faster FDA review process, with a target action date of June 30, 2025, for CUTX-101. How could Cyprium benefit from the CUTX-101 NDA approval?

Priority review, which shortens the standard ten-month FDA review timeline to six months, is typically reserved for drugs that provide a significant improvement in safety or efficacy.