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, ...

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

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

Sanjula Jain-Nagpal, associate director of Policy & Research Strategy at the FDA, will be allowed to remain at the agency but ...

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.

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

Only one clinical-stage asset from the ProfoundBio acquisition remains in development: The antibody-drug conjugate Rina-S, in ...

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