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Latest From Medivation, Inc.
Agency recommendation for randomized controlled trials in ultra-rare pediatric disease is unworkable for various reasons, say advocates and sponsors who seek use of the accelerated approval pathway based on changes in heparan sulfate levels.
Antibodies targeting TIGIT, IL-27, CCR8 and BTLA from the Chinese and US firms are among the first batch of combination candidates expected to expand the indications of anti-PD-1 antibody Loqtorzi beyond the rare condition of nasopharyngeal carcinoma.
The European Medicines Agency has OKd nine new medicines for EU-wide approval, but recommended against renewing the conditional marketing authorization of two drugs.
The European Medicines Agency is set to decide whether to back EU marketing approval for eight new drugs.
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