Tag : EMA

Neurology

EMA Panel Backs Solriamfetol (Sunosi) for Narcolepsy, OSA

Newsemia
The dual-acting dopamine and norepinephrine reuptake inhibitor showed durable effects in reducing excessive sleepiness in patients with narcolepsy or obstructive sleep apnea (OSA). International Approvals...
Latest News

bluebird’s gene therapy gets nod from EMA panel – for real this time

Newsemia
The EMA’s Committee for Human Medicinal Products recommended a conditional approval for Zynteglo in beta-thalassemia. A third-party press release erroneously stated the agency had approved...
Pharma / Biotech

Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?

Newsemia
Related Articles Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse? J Pharm Biomed Anal. 2018 Dec 19;165:381-385 Authors: Kaza M, Karaźniewicz-Łada...
Neurology

EMA Panel Backs First Oral-Only Drug for Deadly Disease

Newsemia
Fexinidazole is for the treatment of human African trypanosomiasis caused by Trypanosoma brucei gambiense in adults and children aged 6 years and older. International Approvals...
Latest News

FDA and EMA accept Novartis' regulatory application for siponimod to treat SPMS in adults

Newsemia
Novartis today announced that both the US Food and Drug Administration and European Medicines Agency have accepted the company’s New Drug Application and Marketing Authorization...
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Celltrion Finalizes Clinical Trials for Remsima SC, Planning to File a Marketing Authorization Application to the EMA in H2

Newsemia
INCHEON, South Korea–(BUSINESS WIRE)–#Celltrion–Celltrion finalizes clinical trials for the patient convenience-enhanced Remsima SC, planning to file a marketing authorization application to the EMA Source link...

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