News

BioSpace6h
GSK’s Blenrep Loses Adcomm Vote, Further Clouding Comeback Bid
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
The Pharma Letter3h
GSK shares slide on FDA’s Blenrep concerns
Oncologic Drugs Advisory Committee has voted against two proposed combination regimens containing GSK’s Blenrep (belantamab ...
Pulmonology Advisor6h
FDA to Review Arexvy for 18 to 49-Year-Olds at Increased RSV Disease Risk
The FDA has accepted for review the sBLA to expand the indication of Arexvy (RSV vaccine, adjuvanted) to adults aged 18 to 49 years who are at increased risk.
BioPharma Dive3h
Bristol Myers’ Reblozyl falls short in Phase 3; Blenrep voted down by FDA panel
The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have ...
US FDA approves pre-filled version of GSK's shingles vaccine
The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK's blockbuster shingles vaccine Shingrix, ...
Fierce Pharma3d
As GSK eyes Blenrep's US return, FDA flags eye safety concerns ahead of advisory committee meeting
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...