News

BofA Maintains a Sell Rating on GSK plc (GSK), Sets a PT of p1,510
The analyst further reasoned that the high ocular toxicity rates, including keratopathy and visual acuity changes, are ...
BioSpace14h
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 ...
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 ...
FDA rejects overall benefit/risk profile of GSK's blood cancer drug dosage
Drugmaker GSK said on Friday that the US Food and Drug Administration's Oncologic Drugs Advisory Committee had voted against ...
Pulmonology Advisor13h
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.
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, ...