PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
REGULATORY
PMDA Reviewing Safety Risks for Carvykti, Keytruda, Tecentriq, and More
The Pharmaceuticals and Medical Devices Agency (PMDA) is looking into new side effect risks for Janssen Pharmaceutical’s CAR-T cell therapy Carvykti (ciltacabtagene autoleucel), as well as PD-1/PD-L1 agents and other drugs, flagging possible label changes in the near future. According…
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