ViiV Healthcare gets European Marketing Authorization for children’s HIV drug
UNITED KINGDOM— ViiV Healthcare has received a positive opinion from the European Medicines Agency...
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Tag: European Medicines Agency
U.S. and EU regulators to expedite reviews of Pfizer’s RSV vaccine
USA — Pfizer has announced that regulatory authorities in the US and Europe have accepted...
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CSL’s Hemgenix becomes first hemophilia B gene therapy approved in EU
NETHERLANDS — The European Commission has approved CSL and uniQure’s gene therapy Hemgenix,...
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Abbott scores FDA, EMA authorizations for cardiac ablation catheter
USA — Abbott has today announced receipt of the CE mark for the TactiFlex ablation catheter,...
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About 100 generic drugs suspended in Europe after data ‘irregularities’ uncovered at Indian CRO
NETHERLANDS – A scientific panel of the European Medicines Agency is set to suspend the use of...
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European drug watchdog backs AstraZeneca COVID-19 prevention jab
NETHERLANDS – The European Union’s drug watchdog has recommended for approval...
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Lundbeck’s Vyepti scores EC approval for migraine prevention
DENMARK – The European Commission has granted marketing authorization of Lundbeck’s...
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Biogen mulls massive layoffs following disappointing Aduhelm rollout: Report
USA – Biogen is planning to lay off over 1000 employees following the disappointing launch...
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Roche’s arthritis drug scores EMA approval for treating severe Covid-19
NETHERLANDS – The European Medicines Agency (EMA) has recommended extending the use of...
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GSK & Vir Biotech sign pact with U.S to supply Covid-19 antibody therapy doses worth US$1 billion
USA – The US government has signed contracts worth approximately US$1 billion to secure the...
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Novavax vaccine nearing approval in the EU
NETHERLANDS – The European Union’s drug regulator has said that it could make a...
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Biogen’s Alzheimer’s drug gets negative vote from European regulators
EUROPE – European Medicines Agency (EMA) panel voted against approval of Biogen Inc’s...
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