The US Food and Drug Administration has published a final draft guidance that addresses what’s expected when sponsors get complete response letters (CRL) to their abbreviated new drug applications ...
As part of efforts to increase transparency and generic drug competition, the US Food and Drug Administration (FDA) is publishing patent submission dates to help generic drug manufacturers determine ...
On Friday, June 12, 2026, the US Food and Drug Administration (FDA) released a draft guidance document, Forms FDA 3542a and FDA 3542: Questions ...
SAN DIEGO, Aug. 19, 2025 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCID: EVFM) today announced that a newly-issued U.S. patent which covers SOLOSEC® (secnidazole) 2 g oral granules and one of its ...
The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva filed a complaint for patent ...
CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative ...
Biofrontera Inc. Announces Patent Approval and Inclusion of Ameluz® Formulation in FDA's Orange Book
Biofrontera Inc. announced that it has received patent approval for a revised formulation of its Ameluz® nanoemulsion gel, which is now listed in the FDA's Orange Book, ensuring patent protection ...
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