regulatory

News

FDA wants to exert regulatory flexibility on cell and gene therapies in an effort to bring them to patients more quickly and efficiently.

News

Vanda will continue to push for approval of Hetlioz for jet lag, despite the FDA saying its trial designs were not satisfactory.

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.