All Conditional marketing authorisation articles
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PodcastsRegRapPod − InConversation with TMC Pharma
InConversation talks about conditional marketing authorisation − and how the work starts after approval – with Catherine Moncad
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JournalThe first approval of a CRISPR-Cas9 gene editing medicinal product in the European Union: Casgevy
Regulatory Rapporteur May 2024 | Volume 21 | No.5 Abstract Patients with transfusion-dependent β-thalassemia and severe sickle cell disease suffer the burden of repeated blood transfusions and vaso-occlusive crises, respectively. Casgevy (exagamglogene autotemcel) consists of autologous CD34+ haematopoietic stem ...
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FocusConditional oncology drug approvals: A sponsor’s perspective on the evolving landscape of FDA accelerated approvals
The FDA’s accelerated approval (AA) pathway is an important regulatory mechanism that allows patients with serious or life-threatening conditions, potentially earlier access to treatments than under a standard, regular approval development pathway...