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Fiscal 2022 is already setting a dismal pace for generic drug approvals, which sunk to a record low last year under the full brunt of COVID-19 supply-chain and clinical trial interruptions. Read More
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