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

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

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

We felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success,” Martin Holst Lange, ...

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

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.

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 ...

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.

Lundbeck had tried to scoop the narcolepsy drug maker out from under Alkeremes with $2.4 billion, but Avadel has elected to ...

Moderna is currently in the middle of an aggressive cost-cutting campaign. In September last year, the company announced that ...

Eli Lilly has broken free from the Big Pharma pack. Fueled by sky-high expectations for the GLP-1 market, Lilly has achieved ...