Reform FDA advisory committees and put rare disease patients first

The Food and Drug Administration (FDA) is failing patients with life-threatening rare diseases. As a biochemist and public ...
Fierce Healthcare

FDA advisory committee to roll up sleeves on generative AI this week

The FDA will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the agency should review medical devices that rely on generative AI, like chatbots. The meeting will be held ...
RAPS

When FDA and Advisory Committees Disagree: Study Investigates Gaps

While only about one in five US Food and Drug Administration (FDA) new drug approvals or safety decisions run counter to outside advisory committee advice, a new study published Monday in the Milbank ...
The American Journal of Managed Care

ISPOR Panelists: Can the FDA Advisory Committee Process Be Strengthened?

Panelists at the leading health economics and outcomes conference discuss whether the FDA's process for allowing outside experts to weigh in on drug approvals needs changes. The share of drugs ...
Healio

FDA advisory committee backs donanemab for early-stage Alzheimer’s

Please provide your email address to receive an email when new articles are posted on . The FDA panel voted 11-0 in favor of donanemab as an effective treatment for early-stage Alzheimer’s. The ...
CNN

FDA advisers weigh benefits of weekly insulin for people with diabetes

Most types of insulin therapy, an important part of diabetes treatment for many people, are given as daily injections to help manage blood sugar levels. Now, the maker of a once-weekly insulin ...
Task & Purpose

FDA Advisory Committee voted against MDMA therapy, what’s next?

An advisory committee to the FDA voted down MDMA-assisted therapy on Tuesday, in what many see as a setback for a possible PTSD treatment. By Joshua Skovlund Published Jun 7, 2024 4:33 PM EDT Add Task ...
Fierce Pharma

FDA hearing on Amgen's Tavneos will include findings from an independent review

An independent research firm is reviewing data on Amgen’s Tavneos as the company prepares for a hearing later this month with ...

FDA advisers to weigh updated COVID vaccine targeting XFG subvariant

The Food and Drug Administration’s (FDA) advisory committee on vaccines this week will consider whether to change the COVID-19 vaccine to target the XFG subvariant for the upcoming 2026-2027 ...