Cardiovascular disease remains the leading global killer. Still, too many late-stage cardiology trials stumble, not for lack of biology, but because episodic, clinic-bound measures miss what matters ...

The US Food and Drug Administration’s (FDA) on Thursday finalized guidance to sponsors on managing multiple endpoints in clinical trials to minimize the likelihood of making false conclusions of a ...

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership of pharma companies, academics, and regulators, including FDA, looking to create a new “gold standard” of clinical ...

Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple ...

Argenica’s ARG-007 shows promising improvements in functional outcomes in Phase II stroke trial ARG-007 treated patients showed efficacy trend over placebo in exploratory functional endpoints On ...