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FDA moves to fast-track 3 psychedelic drugs for review

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 · 10h · on MSN
What is ibogaine? FDA to fast-track review of drugs for mental health
A mind-bending hallucinogen is moving out of the counterculture and into the clinic. The Food and Drug Administration on Friday greenlit the first-ever human clinical trial of an ibogaine derivative in the US,

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 · 1d
FDA moves to fast-track review of psilocybin and methylone for mental health
 · 1d
FDA plans ultra-fast review of three psychedelic drugs following Trump directive
 · 1d
FDA Plans Ultra-Fast Review of Three Psychedelic Drugs Following Trump Directive
The Food and Drug Administration said Friday it will offer ultra-fast review to three psychedelic drugs being developed to treat mental health conditions, including depression, the latest indication o...

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 · 21h
Psychedelics are coming. Are we ready?
Scientific American · 1d
RFK, Jr., puts psychedelics on fast track to FDA review and approval
 · 5h
The FDA just fast-tracked psychedelic drugs to treat depression. They could be here by this summer
Those vouchers shorten the FDA’s review process from its standard 10 to 12 months to just one to two months, meaning FDA-approved psychedelics could arrive as soon as this summer.

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 · 23h
New drug research could help those with depression
Marijuana Moment · 1d
Federal Officials Announce Plan For ‘Accelerating’ Access To Psychedelics For Patients With Mental Health Conditions Following Trump’s Order
1don MSN

The FDA is psyched on psychedelics. Which ones will be studied and why?

After an executive order, the FDA announced it would prioritize the study of some psychedelic drugs for therapeutic use. Which did they choose and why?
FOX 11 Los Angeles
9h

What are peptides? FDA may ease restrictions on unproven health fad

Trendy peptide injections boasted by Health Secretary Robert F. Kennedy Jr. and wellness influencers like Joe Rogan may soon get a boost from the FDA.
JD Supra
2mon

FDA’s PreCheck Pilot Program: What Manufacturers and Investors Need to Know

On Feb. 1, 2026, the FDA officially launched its Manufacturing PreCheck Pilot Program, which is intended to de-risk and accelerate the establishment of U.S. pharmaceutical manufacturing facilities by increasing regulatory predictability, facilitating ...
USA Today
1mon

FDA doesn’t approve leucovorin for autism. What can it be used for?

Corrections and clarifications: Due to an editing error, a previous version of this story mischaracterized the scope of the new FDA approval for leucovorin. In a White House briefing on Sept. 22, Trump, Kennedy, and other officials made several ...
Boston Herald
3mon

What to know about FDA’s review of new Zyn advertising proposal

WASHINGTON (AP) — Americans who smoke may soon be hearing a lot more about Zyn, the flavored nicotine pouches that have generated billions in sales while going viral on social media. Trump signs order on psychedelics to ease FDA restrictions ‘It’s a ...
RAPS
12y

Interview: FDA's UDI Architect Jay Crowley on the Agency's Approach to UDI and Pending Changes

The US Food and Drug Administration (FDA) is, like many device regulatory bodies around the world, preparing to implement a huge overhaul of its medical device systems. Known as the Unique Device Identification (UDI) rule, the US regulator wants to build a ...
JD Supra
1mon

FDA User Fee Act Reauthorization: What Happens Next and Positioning for Possible Reform

U.S. Senate Committee on Health, Education, Labor, and Pensions Chair Bill Cassidy (R-La.) in February 2026 released a report, "Patients and Families First: Building the FDA of the Future," that outlines priorities for modernizing the U.S. Food and Drug ...
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