U.S. regulators have accepted a new submission for Vyglxia, offering the chance at a turnaround for another rare disease ...

The notice adds to growing concerns about the safety of knockoff weight loss drugs, which have remained popular despite FDA ...

Hibsago is viewed as a potential “functional cure” for chronic infections and an important part of the British drugmaker’s ...

Lower-than-expected sales of Xolair stood out as the Swiss drugmaker readies for an onslaught of generic competition for top ...

Shortly after winning a clearance in the skin disease dermatomyositis, brepocitinib posted results suggesting it might also ...

Early CDMO engagement can be valuable, particularly when it helps development teams understand technical requirements, ...

The latest installment in BioPharma Dive’s data visualization-focused series includes a look at Moderna’s meteoric rise in 2026 and a sudden deal surge from Roche.

Roche is paying Hansoh $400 million up front in a broad deal involving several ADCs. Elsewhere, another top investor formed a ...

The acquisition gives the German company a promising blood disorder medicine that passed a Phase 2 test and could threaten a ...

The offering will support a trio of medicines in or nearing clinical testing, as well as earlier research into RNAi ...

Fresh off a $150 million IPO, Tom Miller spoke to BioPharma Dive about the roadshow process and how he sees AI’s role in drug ...

The Series A round, which was led by RA Capital, will help fund the development of two genetic medicines designed to treat an ...