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

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.

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

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 ...

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.

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

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

According to one analyst, the alliance and early data “validate” the oncology work of Vir, which was once purely an ...

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 lawsuit seeks to reverse the abrupt overhaul of the U.S. immunization schedule as well as the federal government’s allegedly “unlawful” reformation of a key vaccine panel.