The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
BUSINESS
Sawai Seeks US Approval for Livalo Generic, Submits ANDA
Sawai Pharmaceutical said on June 16 that the US FDA has accepted an application for the approval of the company’s Livalo (pitavastatin) generic drug, which was submitted by its US subsidiary. This is the first overseas regulatory filing for Sawai,…
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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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