Startups are transforming psychedelic therapy through bioengineering, aiming to eliminate the risks of unpredictable “bad trips."

This article outlines the essential requirements for a successful BLA submission.

The FDA lacks direct oversight of natural medical cannabis products due to its classification as a Schedule I substance.

The Electronic Common Technical Document (eCTD) format is now the standard for regulatory submissions to the FDA.

Elon Musk's Neuralink has achieved a major milestone with FDA authorization for its first human clinical trials.

A well-prepared IND application ensures that clinical trials can begin smoothly and that investigational therapies can move closer to market

In a landmark move, Apple has ventured into the healthcare market by positioning the Apple AirPods Pro 2 as over-the-counter hearing aids.

Quality control (QC) in pharmaceutical production is critical for ensuring the safety, efficacy, and reliability of drug products.