FDA

News

FDA panel votes against Lykos’ pioneer psychedelic therapy

FDA independent advisors have comprehensively voted against the use of Lykos Therapeutics’ therapy for post-traumatic stress disorder (PTSD) based on MDMA, also known as e

News

Astellas refiles CLDN 18.2 cancer drug after FDA knockback

The US FDA has started a fresh review of Astellas' zolbetuximab, trying to become the first claudin (CLDN) 18.2-targeting drug to reach the US market, after turning it dow

R&D

parental permission, child assent, and consent in clinical trials

Parental permission, child assent, and adolescent autonomy i...

As a vulnerable population, children in general must rely on their parents or guardians to provide informed consent for them to participate in research.

News

FDA competition seeks digital endpoints for Parkinson’s

The FDA is asking digital health technology developers to come up with a solution to measuring a common symptom of Parkinson’s disease that can have a serious impact on pa

News

FDA delays decision on Moderna’s RSV vaccine

Moderna’s first attempt to expand its commercial activities beyond COVID-19 vaccines, its respiratory syncytial virus (RSV) shot, has suffered a delay in the US.

News

FDA sets June adcomm date for Lilly’s Alzheimer’s drug

The FDA has confirmed that it will convene an advisory committee meeting on 10th June to discuss Eli Lilly’s Alzheimer’s disease candidate donanemab, after announcing a de

FDA panel votes against Lykos’ pioneer psychedelic therapy

Astellas refiles CLDN 18.2 cancer drug after FDA knockback

Parental permission, child assent, and adolescent autonomy i...

FDA competition seeks digital endpoints for Parkinson’s

FDA delays decision on Moderna’s RSV vaccine

FDA sets June adcomm date for Lilly’s Alzheimer’s drug

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

FDA

Editor's Picks