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FDA hears input on psychedelics, PDUFA, lung cancer's next-gen therapies boost survival

Published

16 September 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at biospace.com →

◆ Verified

Fusion42 · 16 September 2026 · Fusion42 review

The FDA held a public forum to discuss the future of psychedelic therapeutics and a meeting on recommendations for reauthorizing the Prescription Drug User Fee Act (PDUFA) following the launch of its TrialBlazer initiative. Definium Therapeutics achieved a late-stage trial success with its LSD drug, while Novartis faces challenges after setbacks with three assets.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

You face a changing regulatory landscape as psychedelic therapeutics advance toward approval and PDUFA reauthorization opens new pathways for trial funding and drug evaluation. This week matters for your US market access and trial strategy.

◆ Coverage

1 source · 16 Sep 2026

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◆ Topics

Biotechfdapsychedelicspdufadrug-approvalclinical-trials