Amicus Therapeutics, Inc.
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Latest From Amicus Therapeutics, Inc.
EMA OKs Seven New Drugs Including First RSV Vaccine For Older Adults
GSK’s Arexvy vaccine for preventing lower respiratory tract disease caused by respiratory syncytial virus in adults aged 60 years and older is among the latest products that the European Medicines Agency said should be approved for use in the EU.
EMA Decision Time For GSK’s RSV Older Adult Vaccine & Roche’s Glofitamab For LBCL
A number of companies could soon find out whether the European Medicines Agency will back pan-EU marketing approval for their respective products.
Hemophilia B Gene Therapy Among Five Drugs On Track For EU-Wide Approval
Alongside CSL/Behring/uniQure’s Hemgenix (etranacogene dezaparvovec), the European Medicines Agency has given the green light to new drugs for liver cancer, NSCLC, Pompe disease and multiple sclerosis. But it turned down omburtamab for treating the rare cancer, neuroblastoma.
Etranacogene Dezaparvovec, Omburtamab & Tremelimumab Await EMA Verdict
Four of the six products up for a marketing authorization opinion from the EMA’s advisory committee, the CHMP, this week are orphan drugs. One of them, omburtamab, was recently turned down by a US FDA advisory panel.
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