News & Analysis as of August 31, 2025

FDA Approval

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DE Under 3: Retirement of “Chevron Doctrine” Exposed Vulnerability of OFCCP’s Overreaching Interpretations of Some of its Rules
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In Neurelis v. Brenner, The FDA’s “Indication-Specific” View of Orphan Exclusivity is (Again) Struck Down

Mayer Brown on 8/1/2025

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’s BiologicsHQ Monthly Injection - August 2024

Venable LLP on 8/27/2024

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

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Chevron Deference › Loper Bright Enterprises v Raimondo › FDA Approval

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

Venable’s BiologicsHQ Monthly Injection - August 2024

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