The supplemental Biologics License Application for the gastric/GEJ cancer indication is supported by data from the double-blind, placebo-controlled MATTERHORN trial.

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

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 ...

References FDA grants Priority Review to SpringWorks Therapeutics’ New Drug Application for mirdametinib for the treatment of adults and children with NF1-PN. News release. SpringWorks.

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.

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 ...