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
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
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.<
As a scientist focused on tangible data and results, it’s easy to be sceptical about the impact of legislative acts: the path from Congress to the lab is long and winding.
The FDA has issued draft guidance on the use of decentralised clinical trials (DCTs), which are increasingly being used by the pharma industry to tackle issues, such as di
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
Bavarian Nordic is preparing to file for regulatory approval of a vaccine against chikungunya virus after its CHIKV VLP candidate showed protective efficacy in a second ph
To improve trial recruitment, engagement, and retention, and to increase the likelihood that trials reflect what matters most to patients, regulatory authorities increasingly point to metho