GSK eyes up combo approval for previously withdrawn myeloma drug
The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.
GSK's Blenrep treatment accepted for review by FDA
Pharma titan GSK has announced that US regulators have accepted for review Blenrep combinations for the treatment of relapsed ...
Pharmabiz2h
US FDA accepts for review GSK’s Blenrep combinations for the treatment of relapsed/refractory multiple myeloma
US FDA accepts for review GSK’s Blenrep combinations for the treatment of relapsed/refractory multiple myeloma: London, UK Tuesday, November 26, 2024, 09:00 Hrs [IST] GSK plc an ...
GSK :FDA Accepts Blenrep Combination For Review In Treatment Of Relapsed/Refractory Multiple Myeloma
GSK plc (GSK, GSK.L) announced that the US Food and Drug Administration has accepted for review a Biologics License Application (BLA) ...
GSK’s Blenrep Nears FDA Review for Myeloma
GlaxoSmithKline (GB:GSK) has released an update.Don't Miss our Black Friday Offers:Unlock your investing potential with TipRanks Premium - Now ...
GSK's Blenrep combinations accepted for review by US FDA
GSK PLC said on Monday that the US Food & Drug Administration accepted a biologics license application for its Blenrep combinations for the treatment of relapsed and refractory multiple myeloma, both ...
The American Journal of Managed Care6d
OS Better With Belantamab Mafodotin Triplet vs Daratumumab in R/R MM
The key secondary end point of overall survival (OS) was met in the DREAMM-7 trial of belantamab mafodotin (Blenrep; GSK) for the treatment of patients with relapsed/refractory multiple myeloma (R/R ...
GSK's Investigational Liver Disease Candidate Hits Primary Goal In Late-Stage Study To Treat Relentless Itch In Some Patients
GSK's phase 3 GLISTEN trial demonstrated linerixibat's potential to treat relentless itch in PBC patients, meeting its ...
pharmaphorum4d
GSK hails survival data with revived myeloma drug Blenrep
GSK's drive to resurrect its multiple myeloma therapy Blenrep has continued with new data from the DREAMM-7 trial showing an increase in overall survival (OS) with the drug had reached statistical ...
pharmaphorum4d
FDA approves GSK's Blenrep for advanced multiple myeloma
Blenrep, which is predicted by analysts to produce revenues of around $1.5bn in 2026, is an antibody-drug conjugate that works by targeting B-cell maturation antigen (BCMA), a protein commonly ...
Targeted Oncology5d
Target Switch and High-Risk Cohorts Support Talquetamab Use in RRMM
During a Case-Based Roundtable® event, Omar Nadeem, MD, and participants reacted to data from the MonumenTAL-1 trial in the ...
The American Journal of Managed Care5d
Treating Double-Exposed Patients With CLL: A Continued Unmet Need
For patients with chronic lymphocytic leukemia (CLL) treated previously with venetoclax and Bruton’s tyrosine kinase inhibitors, many more trials are needed to pinpoint the best next steps ...