News

FDA Approves Prefilled Syringe Presentation for Shingles Vaccine
Prefilled syringe eliminates the need to reconstitute separate vials prior to administration and simplifies the vaccine ...
GSK's Blood Cancer Drug Faces US Setback Due To FDA Panel's Eye Safety Warning
Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...
Contract Pharma3d
GSK’s Prefilled Syringe Presentation of SHINGRIX Approved by FDA
The U.S. FDA has approved a prefilled syringe presentation of GSK plc’s SHINGRIX for the prevention of shingles.
Pharmaceutical Technology on MSN3d
GSK’s Blenrep faces setback as FDA cancer committee votes against approval
The US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk ...
MPR3d
New Shingrix Prefilled Syringe Simplifies Vaccine Administration Process
The Food and Drug Administration (FDA) has approved a new prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted).
Pulmonology Advisor3d
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.
Devdiscourse3d
Major Shifts in Health Sector: Drug Pricing, Genetic Innovation, and Regulatory Changes
Recent developments in the health sector highlight diverse changes from drug pricing initiatives by Bristol Myers and Pfizer ...
PharmTech3d
FDA Approves Shingrix Prefilled Syringe to Simplify Vaccine Administration
Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...
GSK Shares Drop After FDA Committee Vote Leaves Cancer-Drug Comeback in Doubt
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...
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 ...
FDA approves GSK’s prefilled syringe presentation of Shingrix
Administering Shingrix previously required combining a lyophilised antigen with a liquid adjuvant from two separate vials.
STAT3d
FDA advisers say risks of GSK blood cancer drug outweigh benefits in surprise setback
FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the ...