RAPS

FDA offers new guidance on therapeutic equivalence evaluations

In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment of therapeutic equivalence codes, ...
Seeking Alpha

Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA® (vonoprazan) Tablets Through May 3, 2032

FLORHAM PARK, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal ...
Nasdaq

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 ...
Nasdaq

Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Now Listed in FDA Orange Book

WOBURN, Mass., June 03, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), today ...