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 ...

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 ...

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.

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

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.

A source familiar with the matter said the White House initially requested the resignation of Sanjula Jain-Nagpal, a policy and research official at the FDA.

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

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

The regulator has received reports that a group of patients treated with Adzynma had neutralizing antibodies against the ...