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 sNDA for Abilify Maintena’s Bipolar I Disorder Indication
Otsuka Pharmaceutical and its Danish partner Lundbeck said on December 1 that the US FDA has accepted a supplemental new drug application (sNDA) for Abilify Maintena (aripiprazole), a once-monthly injectable version of Abilify, for the additional indication of bipolar I…
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BUSINESS
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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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