pharmaphorum8d
GSK hits another oncology hurdle as Zejula use is limited again
The label change also comes after GSK voluntarily withdrew another indication for Zejula as a late-line treatment for women with recurrent ovarian cancer, after it emerged that PARP inhibitors may ...
pharmaphorum6d
GSK’s Benlysta claims first FDA okay for lupus kidney damage
GSK got a green light for the subcutaneous formulation in 2017 and last year extended the label of the antibody to include paediatric patients aged over five. Over that period sales have grown ...
GlobalData on MSN22d
FDA expands Pfizer’s RSV vaccine label to include all high-risk adults
The label expansion adds to the existing label for ... Abrysvo’s main competitor is GSK’s Arexvy, which is approved in the ...
FiercePharma22d
GSK answers Pfizer's RSV approval with data targeting matching nod in younger adults
Final results from the trials will be presented at upcoming medical conferences and will be submitted to regulators to support potential label updates, GSK added. Despite the nods from the FDA for ...
Business Wire22d
New Data for AREXVY, GSK’s Respiratory Syncytial Virus Vaccine, Show Potential to Help Protect a Broader Group of Adults at Increased Risk for RSV Disease
About the trial designs NCT06389487 is a phase IIIb open-label study to evaluate the non-inferiority of the immune response and to evaluate the safety of the GSK’s RSV vaccine in adults aged 18 ...