The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump ...

The FDA has introduced ELSA, a groundbreaking AI tool designed to expedite the review process for drugs and medical devices.

Keytruda was approved for locally advanced head and neck cancer before and after surgery, showing improved event-free ...

A new article in the Journal of the American Medical Association said the FDA will implement AI into multiple processes.

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

Several of the committee members asked at Thursday’s meeting about the FDA’s new vaccine approval framework. Some expressed concern that changing the strain targeted in this year’s vaccine ...

Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...

The FDA approved Moderna’s lower-dose COVID-19 vaccine, but only for individuals aged 65 years or older and people aged 12 to ...

We recently wrote an introductory overview of navigating the Common Law Research Exemption and the Hatch-Waxman Safe Harbor ...