regulatory

News

J&J files to expand label of depression drug Spravato

Johnson & Johnson has filed for FDA approval of its antidepressant nasal spray Spravato, hoping to make it the first standalone treatment for adults with treatment-resistant depression

News

CDER director Patrizia Cavazzoni and CBER director Peter Marks

FDA launches innovation hub to spur rare disease R&D

The FDA has said it will create a rare disease innovation hub to help speed the development of new treatments and build connections between developers and the rare disease community.

Digital

Drug development and compliance: 4 Ways AI is impacting phar...

The pharmaceutical industry has long been reliant on rigorous research and development processes to bring life-saving drugs to market.

News

Call goes out for simpler clinical trial regulation in UK

Clinical trials are strictly regulated to ensure patient safety, but the current framework in the UK is stifling early-phase clinical research, making it harder to advance novel therapies t

R&D

Connecting the clinical, regulatory, and commercial dots for...

The path to rare disease product innovation involves interdependencies between clinical, regulatory, and commercial.

News

FDA rejects Novo Nordisk’s weekly basal insulin

Novo Nordisk’s bid to provide a once-weekly basal insulin product for people with diabetes, reducing the number of injections needed, has hit a major hurdle in the US.

J&J files to expand label of depression drug Spravato

FDA launches innovation hub to spur rare disease R&D

Drug development and compliance: 4 Ways AI is impacting phar...

Call goes out for simpler clinical trial regulation in UK

Connecting the clinical, regulatory, and commercial dots for...

FDA rejects Novo Nordisk’s weekly basal insulin

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

regulatory

Editor's Picks