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 - ...

Four months after Avidity’s $11.4 billion buyout, Atrium debuted with $270 million in cash and plans to pick up its ...

Remarks the FDA commissioner made during a CNBC appearance seemed to stoke investor fears that UniQure's gene therapy for Huntington's won't get approved.

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

The AI drug discovery specialist is the fifth biotechnology company to go public in February and priced the sector’s largest new stock offering in nearly three years.

Orforglipron, which could be approved for obesity next quarter, proved superior at cutting blood sugar and body weight — but at the expense of higher side effect rates.

The study result is the latest step forward for a drug Bristol could eventually pay more than $8 billion for and has ...