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Blog Post

FDA’s Bendeka decision reverses approvals of Treanda generics

Yesterday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the...

Blog Post

FDA Announces Policy for Unique Nonproprietary Names for Biologics and Biosimilars

In a Federal Register notice, FDA announced its draft guidance, “Nonproprietary Naming of Biological Products,” in which the agency articulates the need “for biological products licensed...

Blog Post

FDA Announces Policy for Unique Nonproprietary Names for Biologics and Biosimilars

In a Federal Register notice, FDA announced its draft guidance, “Nonproprietary Naming of Biological Products,” in which the agency articulates the need “for biological products licensed...

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