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After a site visit by FDA inspectors yielded a Form 483 for Genzyme Ireland in early 2026, the Sanofi subsidiary is facing further reprimand from the U.S. regulator. | After a site visit by FDA inspectors yielded a Form 483 for Genzyme Ireland in early 2026, the Sanofi subsidiary is facing further reprimand from the U.S. regulator.
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From Indiana to Iceland, the FDA this week disclosed concerns raised during recent visits to a pair of manufacturing sites with…

On the heels of a European Commission probe into whether Sanofi “disparaged” one of its flu vaccine rivals in the marketing of…

FDA warning letter cites Genzyme's Waterford, Ireland site for data integrity failures and improperly canceled deviations…

Following an inspection earlier this year that yielded a Form 483, Indian generics juggernaut Alembic Pharmaceuticals has…

Nine months after raiding the offices of Sanofi in an unan | The European Commission has kicked off formal proceedings in an…

FDA inspected Genzyme facility on the outskirts of Waterford city and found ‘significant violations’