The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
BUSINESS
FDA Accepts NDA for Insomnia Med Lemborexant, Target Date Set for Dec. 27
Eisai and its US partner Imbrium Therapeutics said on March 12 that the US FDA has accepted a new drug application for their insomnia treatment lemborexant, with the target action date under the Prescription Drug User Fee Act (PDUFA) set…
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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…
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