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

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

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

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 ...

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

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.

Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a ...

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

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

Aspen is now also considering the possibility of an initial public offering next year in an effort to bring its cell therapy ...

The nod brings Bayer face-to-face in the market with Boehringer Ingelheim and AstraZeneca, each of which has its own HER2 ...