Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...
IIT Kanpur’s Robotic Exoskeleton Offers New Hope for Stroke Recovery
IIT Kanpur has unveiled the world’s first Brain-Computer Interface (BCI)-based Robotic Hand Exoskeleton in a remarkable ...
FDA Grants Breakthrough Therapy Designation To GSK's GSK5764227 For Bone Cancer
GSK plc (GSK, GSK.L) said that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for GSK5764227, its ...
GlobalData on MSN4d
FDA awards GSA breakthrough status for relapsed osteosarcoma treatment
GSK has gained US Food and Drug Administration (FDA) breakthrough therapy designation (BTD) for its B7-H3-targeted ...
조선일보4d
Korea's Resolute gains FDA breakthrough therapy designation for RZ358 treatment
Koreas Resolute gains FDA breakthrough therapy designation for RZ358 treatment Resolute receives FDA recognition for ...
Cancer Therapy Advisor4d
Novel Antibody-Drug Conjugate Gets Breakthrough Tx Designation for Rel/Ref Osteosarcoma
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.
Targeted Oncology4d
FDA Grants B7-H3–Targeted ADC Breakthrough Status in Osteosarcoma
The FDA’s breakthrough therapy designation for GSK’227 underscores its potential to address the critical unmet needs of ...
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DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, ...
Morningstar5d
Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital hyperinsulinism (HI) Ersodetug continues to advance ...
Cure Today3d
FDA Grants BTD to the ADC GSK’227 in Relapsed/Refractory Osteosarcoma
The FDA has granted BTD to GSK’22, a B7-H3-targeted antibody-drug conjugate, for the treatment of adult patients with ...
Yahoo Finance5d
Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
Breakthrough Therapy Designation for ersodetug is designed to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions that ...