With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

Researchers have applied AI to every step of the drug development process. But this might not be enough to design safe and ...

“We are proud that our advanced modeling and simulation software and consulting services supported the development of the majority of drugs approved by the FDA in 2024 ... in accelerating the drug ...

A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...

Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a novel treatment to treat autism spectrum ...

The FDA granted fast track designation to 64Cu-SAR-bisPSMA for PET imaging of PSMA-positive prostate cancer lesions in ...

Life Molecular Imaging (LMI), an international pharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging, announces that the U.S. Food and ...

Companies say they are working to update their products to comply with the Food and Drug ... had also "already begun the process of removing Red 3 prior to the FDA ruling" on the dye.

At least that's the ruff idea from American biotech company Loyal, which was founded with the idea of creating a drug that ...

Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...