The Pink Sheet’s regularly updated list of products containing new active substances that have been approved for marketing in the EU under the centralized authorization procedure now includes seven new products – Balversa, mRESVIA, Ordspono, Piasky, Tauvid, Winrevair and Adzynma.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add seven new products, including Winrevair, MSD's treatment for pulmonary arterial hypertension.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
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A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.