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.

The U.S. Food and Drug Administration (FDA) says it plans to use artificial intelligence (AI) to help speed the approval of ...

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 ...

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

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

The U.S. FDA has launched Elsa, a cutting-edge generative AI tool designed to enhance efficiency in scientific reviews and ...

The American Board of Cosmetic Surgery (ABCS) announced that a new wrinkle-reducing, Botox-type injectable, Letybo ...

The FDA becomes involved before any new drug molecule is tested in humans. Here’s how upheaval at the agency appears to be affecting specific points in the approval process for new drugs.

Instead, Stealth submitted a new drug application seeking approval of elamipretide, and the FDA issued its refusal-to-file ...

U.S. FDA successfully completed Pre-License Inspection; Company expects facility will meet all requirements to support ...