Accelerated Assessment Requests Fall Flat At EMA
Pharming Awaits Verdict On Leniolisib
Very few companies asked the European Medicines Agency to fast track their drug marketing authorization applications in the first half of this year, and those that did were all turned down.
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EU Fast Track Sought For Epidermolysis Bullosa Gene Therapy & Bispecific RRMM Drug
Janssen and Krystal Biotech will soon learn whether the European Medicines Agency considers their respective products to be of potential major public health interest, particularly from the point of view of therapeutic innovation.
‘Gene Silencing’ Drug Oxlumo Wins English Funding After Alnylam Improves Discount
Health technology assessment institute NICE has reversed its provisional rejection of Oxlumo for treating the rare disease, primary hyperoxaluria type 1.
New EU Filings
Sugemalimab, from CStone Pharmaceuticals/EQRx, for use in combination with chemotherapy as first-line treatment for metastatic non-small cell lung cancer, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.