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.

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

Months after promising help for “hundreds of thousands of kids,” the FDA approved the decades-old medicine for a disease documented in less than 50 people.

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.

The Zepbound developer is joining other drugmakers’ rush into China as it plans to boost its oral solid dosage supply chain ...

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

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 ...

Belgium-based UCB said Wednesday its blockbuster anti-inflammatory drug Bimzelx beat AbbVie’s Skyrizi in a head-to-head trial for active psoriatic arthritis, potentially setting up Bimzelx for a boost ...

The Kanakee project builds on the company’s efforts to increase its U.S. footprint, where it has already spent more than $3 ...