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Celltrion targets European secukinumab market with EMA filing for CT-P55 JD Supra 5d

JD Supra 5d

CT-P55 COSENTYX

EMA selects TrialAssure anonymisation platform for clinical trial documents Pharmafile 13:54 Thu, 30 Jul

Pharmafile 13:54 Thu, 30 Jul

TrialAssure EMA

Atsena gains EMA orphan status for two gene therapies PharmaTimes 12:04 Wed, 29 Jul

PharmaTimes 12:04 Wed, 29 Jul

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EU pharma regulators publish annual AI observatory report Osborne Clarke 13:44 Fri, 31 Jul

Osborne Clarke 13:44 Fri, 31 Jul

Biotechnology AI

EMA issues positive Opinion for orphan drug Designation of imsidolimab for gpp Rare Disease Advisor 18:18 Mon, 27 Jul

Rare Disease Advisor 18:18 Mon, 27 Jul

EMA recommends granting marketing authorisation approval for Nezglyal PMLiVE 12:53 Mon, 27 Jul

PMLiVE 12:53 Mon, 27 Jul

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Latest

Yesterday

Yochanra®, the World's First Innovative Drug to Overcome Fgfr Inhibitor Resistance, Makes Its Global Debut in China PR Newswire (Press Release) 07:55 Fri, 07 Aug

Monday

Celltrion Targets European Secukinumab Market with EMA Filing for CT-P55 JD Supra 19:38 Mon, 03 Aug

U.S. FDA Grants Orphan Drug Designation to Zai Lab’s DLL3-Targeting ADC Zocilurtatug Pelitecan (Zoci) for the Treatment of Neuroendocrine Carcinomas (NECs) Business Wire (Press Release) 12:07 Mon, 03 Aug

In the last month

EU pharma regulators publish annual AI observatory report Osborne Clarke 13:44 Fri, 31 Jul

Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate Business Wire (Press Release) 12:03 Fri, 31 Jul

Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate Business Wire (Press Release) 07:32 Fri, 31 Jul

EMA selects TrialAssure anonymisation platform for clinical trial documents Pharmafile 13:54 Thu, 30 Jul

Zvra Investor Alert: Levi & Korsinsky Notifies Investors of Investigation Into Zevra Therapeutics (Zvra) Business Wire (Press Release) 15:11 Wed, 29 Jul

Atsena gains EMA orphan status for two gene therapies PharmaTimes 12:04 Wed, 29 Jul

TrialAssure selected as EMA’s official clinical trial anonymisation partner Clinical Trials Arena 11:16 Wed, 29 Jul

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Latest news on the European Medicines Agency, also known as the EMA, a European Union agency responsible for the evaluation and supervision of pharmaceuticals.

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