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FDA Approval › Food and Drug Administration (FDA) › Loper Bright Enterprises v Raimondo

Mayer Brown

In Neurelis v. Brenner, The FDA’s “Indication-Specific” View of Orphan Exclusivity is (Again) Struck Down

Mayer Brown on

The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - August 2024

Venable LLP on

Welcome to Venable’s BiologicsHQ Monthly Injection – August 2024...more

Gardner Law

[Hybrid Event] Due Diligence Decoded: M&A Success in FDA-Regulated Industries - September 20th, Boston, MA

Gardner Law on

Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain...more

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