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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, ...
Cure Today17h
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 ...
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
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 ...
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 ...
Drug breakthrough offers hope for advanced prostate cancer patients
Research suggests a new drug slowed the growth of prostate cancer cells, including those with a resistance to the hormone ...
Cancer Therapy Advisor2d
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.
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Breakthrough therapy repairs cartilage damage in under 4 hours
A groundbreaking therapy first introduced by Northwestern University researchers in 2021 has shown promise in regenerating ...
Targeted Oncology1d
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 ...
Denali: Despite ALS Primary Endpoint Failure, Possible Path Forward Remains
Denali Therapeutics Inc.'s stock remains stable despite trial setback in ALS. BLA filing for MPS II treatment on track. Click ...
GlobalData on MSN2d
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 ...
Monthly Prescribing Reference2d
Novel Antibody-Drug Conjugate Gets Breakthrough Tx Designation for R/R 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 ...