EMA accepts Sandoz application for biosim etanercept
The EMA's acceptance follows recent US FDA regulatory submission acceptance
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Browsing Tag
European Medicines Agency
Stempeutics receives ODD in the European Union for Stempeucel
Stempeucel is used in the treatment of Thromboangiitis Obliterans
Possible effects of DE implementation in India
Sankar Sundaram, Professor of Pharmaceutical Sciences, JSS University, talks about data exclusivity and if effective then how it…
India may go to WTO over EU’s drug suspension order of 700 generics
India is examining whether to take up with WTO the EU’s suspension order for sale of about 700 generic drugs which were approved…
Stempeutics receives ATMP classification from EMA for its novel stem cell drug Stempeucel
The first stem cell drug-based on pooling technology to be granted ATMP classification Stempeutics Research, a group company of…
Germany bars Ranbaxy’s antibiotic drug from Dewas plant
The regulator found deficiencies related to operation of drug manufacturing rooms and procedures related to sterilisation of…