Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...
GlobalData on MSN1d
FDA awards GSA breakthrough status for relapsed osteosarcoma treatmentGSK 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, ...
Zacks.com on MSN14h
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy DesignationDenali 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 ...
The FDA has granted BTD to GSK’22, a B7-H3-targeted antibody-drug conjugate, for the treatment of adult patients with ...
Koreas Resolute gains FDA breakthrough therapy designation for RZ358 treatment Resolute receives FDA recognition for ...
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 ...
A German research team’s discoveries about autoimmune diseases are opening up new possibilities for patients with lupus and ...
A team from the Institute of Cancer Research, London, found NXP800 slowed the growth of prostate cancer cells, including ...
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