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

The FDA accepted a supplemental application for Breyanzi to treat adults with relapsed or refractory marginal zone lymphoma ...

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 ...

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

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

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

The regulatory actions were based on results from the Phase III MATTERHORN trial (NCT04592913), which showed that a ...

Syndax Announces FDA Priority Review of sNDA for Revuforj® (revumenib) in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia Provided by GlobeNewswire Jun 24, 2025, 1:01:00 PM ...

The Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for sevabertinib (BAY 2927088), an oral tyrosine kinase inhibitor, for the treatment of adult ...