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regulatory
Pharma
Novo heads to regulators after Sogroya posts positive results
With a late-stage win for its Norditropin heir in hand, Novo Nordisk is making good on plans to boost its profile in the realm of rare disease.
Fraiser Kansteiner
May 13, 2025 9:50am
Compounder in Lilly lawsuit hit with FDA warning letter
Apr 24, 2025 8:20am
FDA asks Novavax for data pledge amid stalled COVID shot review
Apr 23, 2025 9:17am
FDA staff cuts threaten upcoming user fee renewal talks: Reuters
Apr 18, 2025 11:10am
Ex-CBER chief says FDA layoffs threaten future drug reviews: BMO
Apr 17, 2025 2:55pm
Senate confirms surgeon Marty Makary as new FDA commissioner
Mar 26, 2025 10:43am