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 ...

Sprout Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its ...

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 ...

FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025 FDA is expected to notify Innoviva ...

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 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.

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