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

The result “pulls the rug” out from under giredestrant, according to one analyst, sparking another share selloff following disappointing obesity data last week.

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

The agreement ends a messy dispute that began when the telehealth firm attempted to sell a compounded form of Novo’s Wegovy ...

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

The regimen’s clearance in early multiple myeloma was the third approval under the agency’s controversial “national priority” voucher program and issued only 55 days after the review began.

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

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.

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

In his lengthy address Tuesday night, the president touted his efforts to make drugs and insurance more affordable but ...

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

Ingram, who steered the company through multiple drug approvals and controversies, will step aside as Sarepta faces dwindling ...