Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) ...

Enveric Biosciences (ENVB) announces that its wholly-owned subsidiary, Akos Biosciences has entered into two licensing agreements with ...

Enveric's Akos Biosciences licensed its cannabinoid-COX-2 conjugate technology to Restoration Biologics for joint disease ...

Many transgender, nonbinary, and intersex Americans now face uncertainty about the status of their passport applications.

A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...

United Therapeutics Corp. (UTHR), a public benefit corporation, announced Monday that the U.S. Food and Drug Administration (FDA) has ...

The FDA accepted applications for a golimumab biosimilar, while Samsung Biologics reported record sales, and a Japanese ...

Replimune Group, Inc. REPL announced that the FDA has accepted the biologics license application (BLA) for its lead pipeline candidate, RP1 (vusolimogene oderparepvec), in combination with Bristol ...

has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. The FDA granted the BLA Priority Review ...

CRL did not identify deficiencies related to clinical efficacy or safety data in the Biologics License Application (BLA), and the FDA did not request any new clinical studies to support approval ...