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 ...

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 ...

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

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.

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 ...

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.

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 ...