AIIMS researchers claim to have made significant progress in developing chimeric antigen receptor (CAR) T-cell therapy, ...

Tolebrutinib, expected to soon be submitted for U.S. approval for nonrelapsing SPMS, was granted the FDA's breakthrough ...

City of Hope scientists have identified a protein, YTHDF2, that helps cancer cells evade CAR T cell therapy. They developed a ...

Gilead Sciences (NASDAQ:GILD) said it has received FDA Breakthrough Therapy Designation for its antibody-drug conjugate ...

The FDA granted breakthrough therapy designation to dostarlimab for locally advanced dMMR/MSI-H rectal cancer, highlighting ...

Sanofi SNY announced that the FDA has granted a Breakthrough Therapy designation to its investigational oral BTK inhibitor, ...

The Breakthrough Therapy designation is supported by data from the randomized, open-label phase 2 SOLSTICE trial.

Sanofi SNY announced that the FDA has granted a Breakthrough Therapy designation to its investigational oral BTK inhibitor, tolebrutinib, for treating adults with non-relapsing secondary ...

The FDA granted breakthrough therapy designation to sacituzumab govitecan for patients with ES-SCLC progressing on platinum ...

This report examines the potential risks and benefits of receiving breakthrough therapy designation (BTD), compares and contrasts fast-track drug development approaches (logistics, criteria and ...