Gilead Sciences GILD announced that its first-in-class Trop-2-directed antibody-drug conjugate, Trodelvy (sacituzumab ...

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

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

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, tolebrutinib, for treating adults with non-relapsing secondary ...

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

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 ...

Monroe Carell was a natural fit to offer the new therapy. Its multidisciplinary DMD Clinic, co-directed by Burnette, Soslow ...