regulatory

Market Access

At ISPOR EU 2025, a cross-stakeholder panel addressed how Joint Clinical Assessment under the EU HTA Regulation is reshaping evidence strategies.

Digital

For Inventus' Steve Sanghera and Jim Michel 2025 was a year of progress in clinical trial enablement.

News

Sanofi could be months away from wider US approval for Tzield, its drug for delaying the progression of type 1 diabetes, in children as young as one.

News

As the celebrations for the end of 2025 gathered pace, the FDA delivered a year-end blow to Corcept by turning down its new Cushing's drug.

Digital

Digital systems are steadily replacing legacy software and automation tools roll out at speed to cut back the time clinicians spend on manual tasks.

News

FDA has turned down Sanofi's oral BTK inhibitor tolebrutinib for multiple sclerosis, despite suggesting earlier it would delay a decision until 2026.