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As the Omicron variant continues to spread rapidly, the FDA has granted accelerated approval to Gilead Sciences for Veklury (remdesivir), the first FDA-approved COVID-19 treatment for patients outside hospitals who are at high risk of progression to severe COVID-19. Read More
GlaxoSmithKline (GSK) and Vir Biotechnology have developed an intramuscular version of their investigational monoclonal antibody infusion, sotrovimab, for the early treatment of COVID-19 and are asking the FDA to expand the drug’s Emergency Use Authorization (EUA) to include it. Read More
In May 2021, Sotorasib received FDA accelerated approval for the same NSCLC indication, becoming the first KRAS G12 inhibitor to gain regulatory clearance. Read More
In its first-ever FDA approval, Switzerland’s Idorsia has snagged the regulatory green light for Quviviq (daridorexant), a potential blockbuster treatment for adults with insomnia. Read More
The FDA will soon decide whether Eli Lilly’s and Innovent Biologics’ immunotherapy sintilimab can get the go-ahead in the U.S. for the treatment of lung cancer. Read More
An appraisal committee for the UK’s National Institute for Health and Care Evidence (NICE) has recommended against National Health Service (NHS) use of Lynparza (olaparib), AstraZeneca’s blockbuster cancer drug, for treating men with previously treated hormone-resistant metastatic prostate cancer with BRCA1 or BRCA2 mutations. Read More