Tag Archive for: GlaxoSmithKline

GlaxoSmithKline scored a pivotal Priority Review from the FDA for its respiratory syncytial virus (RSV) vaccine candidate for older adults, which will expedite regulatory evaluation of its clinical data. 

GSK beat third-quarter earnings forecasts on Wednesday and raised its 2022 estimate for the second time in four months, continuing its strong start as a standalone prescription medicine business since spinning off its consumer health unit.

Pfizer Inc. said on Tuesday its experimental respiratory syncytial virus (RSV) vaccine was found effective for preventing severe infections in infants after being given in a late-stage study to expectant mothers in the second half of pregnancy.

China has blocked GSK from participating in its national bulk-buy drug procurement program from Oct. 31 until April 29, 2024 over quality problems with a prostate drug, the British drugmaker said on Monday.

U.S. officials are working on a respiratory syncytial virus (RSV) vaccine, but until one is available people should exercise caution, especially seniors and parents of young children, the nation’s top infectious disease official said.

An FDA adcomm that met Wednesday to vote on GlaxoSmithKline’s daprodustat for adult patients with anemia due to chronic kidney disease (CKD) produced mixed results. 

British drugmaker GSK said on Thursday it would not be proceeding with regulatory submissions of its experimental treatment for moderate-to-severe rheumatoid arthritis (RA) after the drug failed to meet a key goal in a study.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee (RDAC) will meet Wednesday to review GlaxoSmithKline’s daprodustat, intended to treat anemia due to chronic kidney disease (CKD) in adults.

Data recently unveiled showed GSK’s respiratory syncytial virus (RSV) vaccine was 82.6% effective in a keenly watched late-stage study involving older adults.

The top pharma companies in 2021 continued to be engaged in creating vaccines and therapeutics, and the investments in R&D led to greater revenue and earnings.