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Celltrion Healthcare Co., Ltd.

http://www.celltrionhealthcare.com

Latest From Celltrion Healthcare Co., Ltd.

More Stelara Biosimilars Line Up For Launch In US And EU

Samsung Bioepis and partner Sandoz have won approval for a third US Stelara biosimilar. Meanwhile, in Europe Celltrion has become the latest firm to qualify for an ustekinumab marketing authorization.

Biosimilars Approvals

First Nasal Adrenaline Spray Among 10 Products Heading For EU-Wide Approval

The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.

Europe Drug Review

EMA Says Yes To 12 New Drugs Including Pfizer/AbbVie’s Antibiotic Combo

Emblaveo, for fighting infections caused by multidrug-resistant bacteria, is among the latest batch of medicines that the European Medicines Agency says should be approved for use in the EU.

Europe Approvals

EMA Decision Time For Aztreonam-Avibactam; High-Stakes Meeting For Lecanamab

The European Medicines Agency is this week deciding whether a number of new drugs should win EU approval.

Europe Approvals
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