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FDA sets out its thinking on psychedelic drug trials

The FDA has published its first-ever guidance document on clinical trials with psychedelic drugs, an emerging treatment category for psychiatric and substance use disorder

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FDA panel vote dashes Intercept’s NASH hopes

Intercept Pharma is facing an uphill battle to get FDA approval of its OCA therapy for non-alcoholic steatohepatitis (NASH) once again, after FDA advisors comprehensively

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FDA still sceptical about Intercept’s NASH drug

Intercept Pharma’s hope that its OCA candidate could become the first FDA-approved drug to treat non-alcoholic steatohepatitis (NASH) is starting to look decidedly faint.

Market Access

The future of biomedical research is animal-free

Despite the subtle change and lack of immediate impact on patients, the FDA Modernization Act 2.0 is anything but inconsequential, as Pepper Bio's Samantha Dale explains

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FDA sets out its thinking on decentralised clinical trials

The FDA has issued draft guidance on the use of decentralised clinical trials (DCTs), which are increasingly being used by the pharma industry to tackle issues, such as di

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Supreme Court presses pause on mifepristone curbs

The US Supreme Court has said it will allow the abortion pill mifepristone to remain available while an appeal of the decision to strike down its regulatory approval make

FDA sets out its thinking on psychedelic drug trials

FDA panel vote dashes Intercept’s NASH hopes

FDA still sceptical about Intercept’s NASH drug

The future of biomedical research is animal-free

FDA sets out its thinking on decentralised clinical trials

Supreme Court presses pause on mifepristone curbs

Roche's IgAN hopeful sefaxersen passes phase 3 test

Discover a new era of healthcare panel engagement: Grounded ...

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