ClinicaSpace

Only with the adoption of digital imaging and AI-powered analysis will next-generation precision oncology therapies reach their full potential and ensure no eligible patient is overlooked.

Despite rehiring hundreds of FDA, CDC and NIH employees, the Department of Health and Human Services is still a skeleton of its former self under Health Secretary Robert F. Kennedy Jr.

Slashing adverse drug reactions through pharmacogenetics and advanced AI could help rehabilitate the pharmaceutical industry’s reputation amid mounting criticism.

Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been attached to approved CAR T cancer therapies reflects “thoughtful consideration of real-world evidence” and “regulatory trust.”

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside experts.

Changing how biopharmas package their products, how regulators review new drugs and how mutated genes are fixed could make ultrarare disease treatments possible.

In the race to make the most tolerable obesity drug, there seems to be no clear winner—at least not according to analysts parsing the data presented at the American Diabetes Association annual meeting this week.

The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from sufficient to maintain momentum in the rare disease space.

The well-respected director of the FDA’s cell and gene therapy office was seen as a stabilizing and trustworthy voice inside the quickly reshaping FDA, especially since the late-March exit of CBER Director Peter Marks.

After the delayed approval of its next-generation COVID-19 vaccine, Novavax now awaits the first meeting of the recently overhauled CDC vaccine advisory committee next week. Throughout a tumultuous season, the Maryland-based company is relying on agility and a diverse pipeline to stay ahead of rapidly changing regulations.