News US and EU regulators collaborate on rare diseases Clinical trial design among areas regulators will collaborate on
Views & Analysis Meeting pharmacovigilance standards in the US and Europe Examining statistics on recent inspections gives insight into the issues commonly faced.
News German watchdog criticises EMA adaptive pathways approval Cost effectiveness agency critical of real world evidence plans
News Immunotherapy for brain cancer gets European PRIME status Latest addition to EMA's fast-track for cutting edge drugs
News Sandoz, Teva and Mylan generics to be suspended in EU Regulator concerned over data from contract research organisation.
Views & Analysis Are European incentives speeding access in rare cancer treat... Examining the impact of support programmes for orphan treatments.
News Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer Eli Lilly's imlunestrant (Inluriyo) for breast cancer has received a new FDA approval, in combination with CDK4/6 inhibitor abemaciclib (Verzenio).
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