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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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.
A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is being introduced in New Zealand, where the new coalition government is working to repeal last year’s landmark Therapeutic Products Act.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add three new products, including Velsipity, Pfizer's treatment for moderately to severely active ulcerative colitis in patients 16 years of age and older.