US Food and Drug Administration (FDA) updates Winrevair (sotatercept) label based on new trial data supporting earlier use in pulmonary arterial hypertension

The US Food and Drug Administration (FDA) has approved an update to the US label for WINREVAIR (sotatercept-csrk), Merck’s activin signaling inhibitor for pulmonary arterial hypertension, to include efficacy and safety data from the Phase 3 HYPERION trial. The trial specifically evaluated adults newly diagnosed with pulmonary arterial hypertension — within 12 months of screening, […]

US Food and Drug Administration (FDA) updates Winrevair (sotatercept) label based on new trial data supporting earlier use in pulmonary arterial hypertension Read Post »

The US Food and Drug Administration (FDA) issues guidance to medical product sponsors to ensure greater inclusivity in clinical trials, June 26, 2024

The U.S. Food and Drug Administration (FDA) has issued a draft guidance titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” This guidance is aimed at assisting medical product sponsors in submitting “Diversity Action Plans” for certain clinical studies. These plans are designed to enhance the enrollment of historically

The US Food and Drug Administration (FDA) issues guidance to medical product sponsors to ensure greater inclusivity in clinical trials, June 26, 2024 Read Post »

The EU Clinical Trials Regulation came into force 31st of January 2022

The European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation comes into force today, the 31st of January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. Prior to

The EU Clinical Trials Regulation came into force 31st of January 2022 Read Post »

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