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 ...

US FDA accepts for priority review Bristol Myers Squibb’s sBLA for Breyanzi to treat adult patients with relapsed or refractory MZL: Princeton, New Jersey Wednesday, August 6, 2 ...

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 ...

In the U.S., a rare disease is defined as one that affects fewer than 200,000 people. This status allows for priority review, fast track status and breakthrough therapy designation.

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema ...

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 granted Priority Review to TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder ...

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