Medscape

In the Race to the First Psychedelic Approval, Who’s Leading?

A new FDA regulatory pathway could accelerate approval of psychedelic therapies for resistant depression and PTSD, and ...
Neurology Advisor

FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

The FDA is testing real-time clinical trial reporting in an effort to speed up the drug review and approval process.

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
Texas Public Radio

Psychedelic treatments are on the verge of FDA approval. Why Texas is pushing for them, and how Texans could gain access

Texas is helping shape the future of psychedelic therapies. Here’s how they work and what access could look like.
Scientific American

Why the FDA rejected a ‘breakthrough’ melanoma drug

The FDA rejected the promising skin cancer drug RP1 twice, leaving many puzzled and worried about what this means for other ...

i-GENTIC AI Expands GENIE to Enforce Full FDA Compliance Lifecycle for Life Sciences

GENIE is the first real-time, LLM-agnostic intelligence engine that converts complex regulations into machine-executable logic for compliance enforcement. i-GENTIC introduces a level of trust and ...
Regulatory Affairs Professionals Society

FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...

Watch CNBC's full interview with FDA Commissioner Marty Makary

FDA Commissioner Marty Makary sits down with CNBC's David Faber to discuss recent headlines surrounding the agency, recent ...

Corcept: 'Strong Buy' On Lifyorli FDA Approval And ALS Phase 3 Advancement

Corcept Therapeutics Incorporated is a Strong Buy after early FDA approval of Lyforli for PROC, with upside from EU decisions ...