NLS Biotech News

Biotech Business – November 28, 2025

FDA grants Medivir’s MIV-711 Orphan Drug Designation

Medivir’s selective cathepsin K inhibitor, MIV-711, has been granted Orphan Drug Designation (ODD) by the FDA for the treatment of Osteogenesis Imperfecta (OI).

Biotech Business – November 24, 2025

Alvotech receives European approval of a biosimilar to Prolia and Xgeva

“This milestone reflects not only the dedication and expertise of our teams, but also the strong partnerships we have built to bring affordable medicines to patients across Europe,” says Robert Wessman, Chairman and Chief Executive Officer of Alvotech.

Agreement – November 24, 2025

Sprint Bioscience sells the TREX1 program to Gilead

The agreement includes an upfront payment of USD 14 million, as well as potential clinical, regulatory, and commercial milestone payments totaling up to USD 400 million.

Biotech Business – November 21, 2025

Alvotech and Advanz Pharma receive marketing approval across the European Economic Area

The European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz, Alvotech’s biosimilar to Simponi (golimumab).

Biotech Business – November 18, 2025

Sofinnova announces USD 750M fund that will invest in early stage biotechs

European life science VC firm Sofinnova Partners has announced the close of its latest flagship fund, Sofinnova Capital XI, at EUR 650 million (USD 750 million).

Clinical trials

Profiles in Biotech

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