GlaxoSmithKline
NEWS
GSK bolstered its position in the oligonucleotide therapeutics space through a four-year collaboration with Wave Life Sciences valued at up to $3.3 billion.
GSK intends to file for approval of Jemperli in endometrial cancer after the checkpoint inhibitor met its primary endpoint in the Phase III RUBY trial.
Following a request from the FDA, GSK is withdrawing its multiple myeloma drug Blenrep from the U.S. market while continuing to push other combination trial programs.
At the FDA’s request, GSK has restricted the use of Zejula, a PARP inhibitor, to a specific population as a second-line maintenance treatment for ovarian cancer following updated data.
GSK is planning a Phase III trial evaluating bepirovirsen as a potential functional cure for chronic hepatitis B infection, despite the most recently released data appearing less robust than the interim analyses.
GSKs Blenrep misses the mark in the Phase III DREAMM-3 trial for relapsed or refractory multiple myeloma (RRMM), possibly putting the drug’s continued approval at risk.
GSK scored a pivotal Priority Review from the FDA for its RSV vaccine candidate for older adults, which will expedite regulatory evaluation of its clinical data.
GSK is pulling the plug on an experimental monoclonal antibody therapy for rheumatoid arthritis following a significant miss in one of three Phase III trials.
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.
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