The supplemental New Drug Application is supported by data from the Phase II TRANSCEND FL trial (NCT04245839), which showed ...

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 ...

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

We recently compiled a list of 11 Best Future Stocks to Buy Now. Denali Therapeutics Inc. stands sixth on our list among the ...

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.

2024 Priority Gold Review: Comprehensive analysis of customer reviews, complaints, and reputation highlights company performance. SHERMAN OAKS, CALIFORNIA, UNITED STATES, August 17, 2024 ...

The FDA granted the priority review based on findings from the phase 3 KEYNOTE-A18 clinical trial (also known in Europe as ENGOT-cx11/GOG-3047) that showed that Keytruda plus concurrent ...

For " priority reviews, " a designation available for drugs offering significant improvements in safety or effectiveness for serious conditions, the performance goal is 6 months.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab as an add-on maintenance treatment for adolescents aged ...

By granting priority review, the FDA commits to making a decision within six months. Gleevec was approved more than a year ago for treating a type of leukemia when the disease is in its later stages.