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Compliance
Compliance
FDA hits Simtra BioPharma Solutions with warning letter over German site
The agency cited the CDMO’s significant violations of current Good Manufacturing Practice regulations for finished pharmaceuticals at Simtra’s Halle/Westfalen facility.
March 16, 2026
Compliance
Novo Nordisk gets Form 483 from FDA after inspection at Plainsboro, NJ site
March 11, 2026
Compliance
FDA regulatory actions regarding Novo Nordisk site result in CRL for Incyte
March 10, 2026
Compliance
Supreme Court rules against Trump’s ‘reciprocal’ tariffs, pharma not directly impacted
Feb. 20, 2026
Compliance
Pentagon adds WuXi AppTec to list of ‘Chinese military companies’ but then removes it
Feb. 16, 2026
Regulatory Guidance
FDA PreCheck pilot program accepts applications, looks to speed up US buildouts
Feb. 2, 2026
Compliance
Top 7 pharma manufacturing regulatory stories of 2025
Dec. 29, 2025
Compliance
Trump inks drug pricing, tariff deals with nine biopharma companies
Dec. 22, 2025
Compliance
FDA slaps Novo Nordisk with warning letter over former Catalent site in Indiana
Dec. 18, 2025
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