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Roche launches global Phase III Elevidys trial to support EU approval for Duchenne gene therapy Manufacturing Chemist 12:27 Fri, 17 Apr

Manufacturing Chemist 12:27 Fri, 17 Apr

Disability Biology

Ray Therapeutics receives EMA PRIME status for gene therapy Hospital Management 6d

Hospital Management 6d

FDA and EMA accept teva’s omalizumab biosimilar applications JD Supra 20:03 Wed, 15 Apr

JD Supra 20:03 Wed, 15 Apr

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Celltrion files Herceptin biosimilar SC formulation with EMA Korea Biomedical Review 6d

Korea Biomedical Review 6d

Acr/EULAR classification criteria superior to ped-EMA criteria for pediatric AAV Rare Disease Advisor 15:20 Fri, 17 Apr

Rare Disease Advisor 15:20 Fri, 17 Apr

New EU pilot programme for breakthrough medical devices and in vitro diagnostics JD Supra 16:47 Thu, 16 Apr

JD Supra 16:47 Thu, 16 Apr

European Commission

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Latest

Thursday

EU pilot programme for breakthrough medical devices: applications open JD Supra 19:53 Thu, 30 Apr

Os Therapeutics: EMA Begins Rolling Review Of Ost-HER2, Stock Up RTT News 15:52 Thu, 30 Apr

Ray Therapeutics receives EMA PRIME status for gene therapy Hospital Management 10:21 Thu, 30 Apr

Celltrion files Herceptin biosimilar SC formulation with EMA Korea Biomedical Review 09:03 Thu, 30 Apr

In the last month

Ray Therapeutics Granted Priority Medicines (prime) Designation from the European Medicines Agency for RTx-015 in Retinitis Pigmentosa Business Wire (Press Release) 13:04 Wed, 29 Apr

Soligenix Announces Interim Results from the Phase 3 FLASH2 Trial Evaluating HyBryte™ in Treatment of Cutaneous T-Cell Lymphoma PR Newswire (Press Release) 12:30 Tue, 28 Apr

VectorY Therapeutics Receives U.K. Mhra Authorization and EMA Approval to Initiate Phase 1/2 pioneer-Als Clinical Trial of VTx-002 in People Living with Amyotrophic Lateral Sclerosis (Als) Business Wire (Press Release) 12:02 Tue, 28 Apr

EMA backs plozasiran for rare lipid disorder with high pancreatitis risk Pharmafile 11:08 Mon, 27 Apr

Novartis Regulatory Wins Raise Questions On Growth And Valuation Gap Simply Wall St 10:57 Sun, 26 Apr

Arrowhead Pharmaceuticals Receives Positive Chmp Opinion Recommending Approval of Redemplo® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS) in Europe Business Wire (Press Release) 11:40 Fri, 24 Apr

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