Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...

Research suggests a new drug slowed the growth of prostate cancer cells, including those with a resistance to the hormone ...

GSK has gained US Food and Drug Administration (FDA) breakthrough therapy designation (BTD) for its B7-H3-targeted ...

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced a significant milestone for its proprietary Nectin-4 targeted ADC (9MW2821). On January 8, 2025, ...

Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, ...

GSK plc (GSK, GSK.L) said that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for GSK5764227, its ...

Koreas Resolute gains FDA breakthrough therapy designation for RZ358 treatment Resolute receives FDA recognition for ...

The FDA has granted BTD to GSK’22, a B7-H3-targeted antibody-drug conjugate, for the treatment of adult patients with ...

GSK5764227 (HS-20093) is a novel antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload.

The FDA’s breakthrough therapy designation for GSK’227 underscores its potential to address the critical unmet needs of ...

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to GSK5764227 (GSK’227) for the treatment of adult patients with relapsed or refractory (R/R) osteosarcoma who have ...

Sana Biotechnology, Inc. shares surge as a breakthrough in diabetes therapy sparks investor interest. Click for my updated ...