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Form 483

Asia
Pharma

Trump's tariffs, Leqembi, Kyowa Kirin—Fierce Pharma Asia

U.S. pharma tariffs are expected "in the next months or two." Leqembi won approval in the EU. Kyowa Kirin completed a biologics plant. And more.
Angus Liu Apr 18, 2025 9:25am
FDA

Aurobindo discloses FDA Form 483 at North Carolina inhaler plant

Apr 14, 2025 3:00pm
Asia

Eisai, ex-NMPA official, Pfizer-Summit—Fierce Pharma Asia

Feb 28, 2025 8:45am
inspection investigation FDA FDA inspection

FDA hits Piramal with 6-observation Form 483 at India API plant

Feb 26, 2025 10:22am
Novo

FDA scrutinizes Novo on production issues at semaglutide plant

Oct 31, 2024 9:33am
Thermo Fisher Scientific headquarters

FDA found contamination issues at Thermo Fisher NC plant

Oct 11, 2024 10:42am

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