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BeiGene’s anti-PD-1 monoclonal antibody tislelizumab has racked up more positive phase 3 numbers, proving itself just as good as sorafenib in extending the lives of patients with unresectable hepatocellular carcinoma. Read More
Abecma (idecabtagene vicleucel), a first-in-class CAR-T cell treatment codeveloped by Bristol Myers Squibb and 2seventybio, significantly improved progression-free survival relative to standard therapy in patients with relapsed multiple myeloma, the companies reported. Read More
Armed with positive results from two late-stage studies, Germany’s Novaliq has submitted a New Drug Application (NDA) to the FDA for its novel treatment for dry eye disease. Read More
Two device companies that share the same address in Natick, Mass., have received separate warning letters from the FDA for quality system failures observed during an FDA inspection, including not fully investigating complaints and a lack of adequate corrective and preventive actions (CAPA). Read More