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EMA European Medicines Agency
EMA European Medicines Agency
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Trending Articles
Catalent and AstraZeneca to expand support for COVID-19 vaccine AZD1222
Catalent will prepare the Harmans facility, close to Baltimore-Washington International (BWI) airport, to enable multiple production trains to run in parallel to produce the...
Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success
Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for...
LUNA 3: Rilzabrutinib Phase III immune thrombocytopenia trial meets primary endpoint
Rilzabrutinib met both the primary endpoint of durable platelet response and various secondary endpoints in patients who were refractory to prior therapy
Memel Biotech and Therabest collaborate to develop exosome-based cell therapies
The partnership will aim to develop, manufacture and distribute novel exosome cell therapies in a range of therapeutic areas
Ipsen and Skyhawk Therapeutics partner to develop RNA-targeting drug candidates
The USD $1.8bn deal will support the development of novel RNA-modulating drugs using Skyhawk's proprietary technology
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EMA issues positive opinion on Calliditas' orphan drug
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Moderna receives positive opinion from the EMA for Spikevax
Moderna has revealed the European Medicine's Agency (EMA) has provided positive opinion on its COVID-19 vaccine Spikevax's marketing authorisation
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EMA celebrates 25 years of regulatory management
The EMA was founded in January 1995
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EMA publishes draft guideline on quality requirements for DDCs
The latest document focuses on combinations of medicinal products and medical devices
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GMP inspection in Bulgaria and Cyprus now on par with US
A mutual recognition agreement between the EU and the US regulatory bodies aims to encompass all EU member states, now standing at 24 of the 28
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Brexit update: UK Inspection Reports and GMP Certificates
The ECA Academy sheds light on the latest Brexit guidance documents released by the European Medicines Agency
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Poland and Slovenia join EU-US mutual recognition agreement for inspections
GMP drug plant inspections conducted by health authorities in Poland and Slovenia will now be accepted by the US FDA
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