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EMA European Medicines Agency
EMA European Medicines Agency
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Trending Articles
Agilent boosts contract manufacturing capabilities with acquisition of BIOVECTRA
The CDMO acquisition will bolster Agilent's end-to-end production capabilities in a number of popular therapeutics, including GLP-1 medications and ADCs
Therapeutic: ensifentrine for chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease (COPD) comes in various guises, including chronic bronchitis and emphysema; and, although incurable, the symptoms can be managed with...
Merck’s clesrovimab meets all primary endpoints in Phase IIb/III trial for RSV in infants
A teaser of the Phase IIb/III trial released by Merck indicates that clesrovimab can reduce the need to medically attend lower respiratory infections caused by RSV in infants
Bringing biotech to the Baltics: the rise of Lithuania
Lithuania’s biotechnology competencies lie in cell and gene therapies, enzymes and the wider pharmaceutical industry, offering companies a rich pool of talent in a...
Currax to build novel anti-obesity treatment production facility amidst GLP-1 supply issues
The manufacturing facility will be dedicated to the production of anti-obesity drug Contrave, and will double its output in the EU and EEA
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EMA issues positive opinion on Calliditas' orphan drug
Calliditas' application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome has received a positive opinion from European Medicines Agency
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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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