All Conditional Approval articles
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JournalRecent advances and the near-term outlook for Advanced Therapy Medicinal Products in cancer treatment
With ATMPs bringing new promise to the treatment of cancer, this article assesses recent clinical developments, how regulators are responding to these advances and how this will impact patient access in the future.
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Industry newsFirst anaemia drug for cats given ‘expanded conditional approval’
Varenzin-CA1 is the first drug approved for cats with nonregenerative
anaemia, under the FDA’s expanded conditional approval pathway. -
CPD SupplementThe Olaratumab experience
As highlighted within this CPD article, a conditional marketing authorisation (CMA) can be revoked in Europe. However only one occurrence has occurred since 2006 (in April 2019). Lartruvo (olaratumab), a humanised antibody, was granted a CMA via accelerated assessment on 9 November 2016 for adult patients with a locally advanced, ...
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CPD SupplementExpedited drug development regulatory pathways in the EU and the US
This continuing professional development (CPD) supplement focuses on the regulatory framework available to drug developers for expediting their products’ development and review processes in the EU and US. These mechanisms are relevant for products which address an unmet medical need in the treatment of a serious and/or life-threatening condition.