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FDA rejects Sobi’s gout drug over manufacturing issues, sparing Amgen blockbuster
Sobi’s plan to introduce a challenger to Amgen’s blockbuster gout drug Krystexxa has been put on hold by the FDA. | Sobi’s plan to introduce a challenger to Amgen’s blockbuster gout drug Krystexxa has been put on hold by the FDA.
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fiercepharma.com
Europe's CHMP reverses endorsement of Amgen's Tavneos as FDA hearing looms
As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators recommending that the ANCA-associated vasculitis…
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endpoints.news
Sobi receives CRL for gout combination drug over manufacturing
The FDA has issued Sobi, also known as Swedish Orphan Biovitrum, a complete response letter for its combination gout treatment over production concerns and issues with its…
