Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Phase 1 results show that SUL-238 is safe, well-tolerated, and demonstrates favorable pharmacokinetics with high CSF ...

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

A new compound, called VU319, has delivered promising results in a Phase 1 trial for treating Alzheimer’s disease and other neudegenerative conditions. The corresponding study was published in ACS ...

In the increasingly complex healthcare realm, a regular flow of drug introductions offers potential benefits to millions of patients. However, the biotech and pharmaceutical companies that develop ...

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

The Congressional Budget Office (CBO) informs Congress about the costs or revenue changes associated with proposed legislation, a challenging enough task on its own. Sometimes, the CBO is asked to ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Standard treatment for breathing problems caused by obstructive sleep apnea is a medical device. But many people find it uncomfortable to wear the mask that comes with a continuous positive airway ...

The Inflation Reduction Act (IRA) of 2022 mandates price negotiations for certain drugs under Medicare, shortening the exclusivity period historically used to recoup research and development ...