Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, ...
Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...
Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for the treatment ...
GlobalData on MSN2d
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 ...
Research suggests a new drug slowed the growth of prostate cancer cells, including those with a resistance to the hormone ...
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 has granted BTD to GSK’22, a B7-H3-targeted antibody-drug conjugate, for the treatment of adult patients with ...
The FDA’s breakthrough therapy designation for GSK’227 underscores its potential to address the critical unmet needs of ...
Zacks.com on MSN2d
GSK's ADC Drug Gets FDA's Breakthrough Tag for Rare Bone CancerThe FDA bestows a Breakthrough Therapy designation to GSK's antibody-drug conjugate, GSK5764227, for treating relapsed or refractory osteosarcoma.
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 ...
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