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

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

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

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

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

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

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

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

Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only ...

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

We felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success,” Martin Holst Lange, Novo’s R&D chief, said on Monday.

Asundexian’s Phase III win could also bode well for Bristol Myers Squibb, which is also developing a Factor XIa inhibitor called milvexian for stroke prevention, analysts said.