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The European Medicines Agency’s (EMA) human medicines committee endorsed seven drugs for new indications during its monthly meeting last week, including Pfizer’s highly effective COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir). Read More
Regeneron Pharmaceuticals and Sanofi are pulling their supplemental Biologics License Application (sBLA) for the indication of cervical cancer for their human monoclonal antibody, Libtayo (cemiplimab-rwlc). Read More
Immunocore’s Kimmtrak (tebentafusp-tebn) has won FDA approval for treating inoperable or metastatic uveal melanoma, a rare adult eye cancer with poor prognosis. Read More
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