The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
BUSINESS
Approval for Once-Monthly Aripiprazole Hits Snag in US: Otsuka
In a Complete Response Letter (CRL) from the US FDA, which Otsuka Pharmaceutical received on July 26 (US local time) for the extended release injection (once-monthly administration) for the antipsychotic Abilify (aripiprazole), it was pointed out that deficiencies were found…
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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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