The approval represents a win in what’s been a difficult regulatory environment of late for vaccine makers, and could boost uptake of a shot that’s posted flattening sales after an initially strong ...

The trial clearance for Shanghai-based Unixell is another step forward for the rapidly advancing Chinese biotech ecosystem, which has invested heavily in cell and gene therapy technology.

Evotec will cut 800 employees in its second layoff round since 2024. Elsewhere, Ultragenyx got a needed win and a twice-rejected cell therapy is getting an audience at the FDA.

Combining the disparate databases used to detect potential issues with drugs, vaccines and other products into a single dashboard will enhance their utility and cut costs, the agency said.

Ugur Sahin and Özlem Türeci, who directed the COVID vaccine maker’s rise to prominence, will helm an as-yet-unnamed company ...

More early-stage data show the drug, called salanersen, appeared to have positive effects on neurodegeneration and motor function in patients previously treated with Novartis' Zolgensma.

Xenon shares skyrocketed nearly 50% on results that handily beat Wall Street expectations. Elsewhere, Capricor got a decision date for a spurned cell therapy and AbbVie and Regeneron showcased obesity ...

Lilly asked the FDA to step in after claiming that testing it’s done suggests copycat versions of Zepbound may carry “unknown ...

Incubated by Atlas Venture, the biotech startup is advancing a daily pill it sees potentially helping people with dystonia or ...

Ipsen found cases of secondary malignancies in a confirmatory study of Tavzerik, a medicine it got in a purchase of Epizyme ...

Company shares surged in after-market trading on results for a drug Vertex acquired in a multibillion-dollar deal and sees as ...

Prasad contributed to an uncertain regulatory climate for gene therapy makers focused on rare conditions. Shares of many ...