NLS Pharma Business

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the company’s drug candidate TCP-25 for the treatment of the severe disease Epidermolysis Bullosa (EB).

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy.

Diamyd Medical provides an update following the receipt of final meeting minutes from a positive Type C meeting with the U.S. Food and Drug Administration (FDA) held in December 2024.

AnaCardio has announced the completion of a USD 19 million Series A extension financing round, co-led by Novo Holdings, Pureos Bioventures and Sound Bioventures. Current investors Flerie, Industrifonden, and Fredrik and Ann-Helene Ljungström, also participated to complete the round.

Novo Nordisk and Valo Health have entered into an expanded agreement to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular disease based on Valo’s human dataset and computation powered by artificial intelligence (AI).

Novo Nordisk has announced plans to establish a completely new production facility in Odense, Denmark.