Candid, which is making bispecifics for immune diseases, has also raised $505 million in a private financing for the newly formed company.

Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.

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

Liver-related side effects have led some analysts to question fenebrutinib’s prospects, even though the drug has now cleared ...

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.

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