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Long-lasting opioid treatment recommended by an EMA committee europeanpharmaceuticalreview
May 05, 2019
Marketing authorisation has been recommended in the EU by an EMA committee for Sixmo (buprenorphine) as a substitution treatment for opioid dependence.
Application to EMA filed for the approval of oral semaglutide europeanpharmaceuticalreview
April 30, 2019
It has been announced that a Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMA) for oral semaglutide.
Strengthened guidance on follow-up and risk management for ATMP developers europeanpharmaceuticalreview
April 29, 2019
Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation…
Pharma firms step up plans to beat Brexit supply chain disruption europeanpharmaceuticalreview
April 19, 2019
The EMA has revised downwards the number of medicines expected to face Brexit-related supply disruptions from 108, earlier this year, to a current level of 39…
Use of Genzyme's MS drug Lemtrada restricted under ongoing EMA safety review pharmafile
April 17, 2019
The EMA has launched a review into Genzyme’s multiple sclerosis drug Lemtrada (alemtuzumab) after reports emerged of treatment-related safety issues arising from heart
EMA recommends temporarily restricting Lemtrada use in MS pharmatimes
April 16, 2019
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a ……
EMA restricts use of multiple sclerosis medicine, Lemtrada europeanpharmaceuticalreview
April 16, 2019
EMA restricts use of multiple sclerosis medicine, Lemtrada.
Positive Scientific Advice from European Medicines Agency for Chronocort firstwordpharma
April 12, 2019
European Medicines Agency confirms the current clinical and regulatory path for Chronocort®...
AVEO Oncology warns of "regulatory action" by EMA if overall survival results for Fotivda come up short firstwordpharma
April 04, 2019
AVEO Oncology disclosed in a filing with the US Securities and Exchange Commission that the European Medicines ……
AVEO Oncology warns of "regulatory action" by EMA if overall survival results for Fotivda come up short pharmatimes
April 04, 2019
AVEO Oncology disclosed in a filing with the US Securities and Exchange Commission that the European Medicines Agency will consider "regulatory action" if an interim overall survival (OS) analysis from the TIVO-3 trial confirms a negative trend for Fotivd

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