New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
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The loss of fast-track status for setmelanotide at the European Medicines Agency means the review of the potential treatment of two rare genetic disorders of obesity will take longer than Rhythm Pharmaceuticals had originally hoped.
The European Medicines Agency will continue working over the Christmas period so that it can complete its assessment of the newly filed marketing applications for BioNTech/Pfizer’s and Moderna’s COVID-19 vaccines as soon possible.
Health technology assessment body says that while iRhythm Technologies’ Zio XT service improves cardiac arrhythmia detection, more data must be collected to address evidence gaps about its benefit.