Tecvayli plus Darzalex led to an 83% boost to progression-free survival versus the current standard therapy in relapsed or ...

Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them ...

Alicia Jackson formerly served as deputy director of the Biological Technologies Office at the Defense Advanced Research ...

Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several ...

At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data ...

The FDA approved an intrathecal form of Novartis’ spinal muscular atrophy gene therapy Zolgensma on Monday, broadening access ...

Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production ...

Novo Nordisk’s amycretin showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes, suggesting its efficacy could become even stronger with longer follow-up, according to analysts ...

Analysts agree that the failure of Novo Nordisk’s semaglutide to reduce Alzheimer’s disease progression removes a “modest” or ...

Johnson & Johnson will discontinue the Phase II Auτonomy study of posdinemab after a scheduled review found the anti-tau ...

Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for ...

NervGen will meet with the FDA early next year to align on a regulatory path forward for NVG-291 in chronic spinal cord ...