The European Medicines Agency is this week due to decide whether to recommend pan-EU marketing approval for 15 new products, including talquetamab, Janssen’s investigational bispecific antibody for treating patients with relapsed or refractory multiple myeloma (RRMM).
EU Decision Time For Janssen’s Talquetamab & 14 Other Products, But MSD Withdraws Lagevrio Filing
A bumper crop of products are up for an opinion this week by the European Medicines Agency’s human medicines committee, the CHMP, as to whether they should be approved in the EU.
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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 Two companies have withdrawn their marketing authorization applications.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 Two companies have withdrawn their marketing authorization applications.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.