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.

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.

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

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.

In issuing a positive recommendation, the EMA has diverged from the FDA, which has set higher approval standards for ...

The proposed acquisition would hand Servier a couple experimental drugs in human testing as well as Ojemda, an approved ...

The detection of certain cardiac issues in a study of healthy volunteers led Aardvark to pause a Phase 3 trial only months before an expected data readout.

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

Cell therapy manufacturing is uniquely vulnerable to contamination, variability, and operational burden because the product - ...

Yuviwel, a once-weekly injection, will now compete for market share with BioMarin’s lucrative daily shot Voxzogo.

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

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