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 ...

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.

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.

Nature Reviews Clinical Oncology 15, 731-747. Media Chunhua Lu 86-10-66609879 [email protected] Investors 86-10-66609999 [email protected] ...