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Results For "EMA"

2381 News Found

Zymo Research receives CE Mark for new Covid-19 SafeCollect kits
Drug Approval | September 01, 2021

Zymo Research receives CE Mark for new Covid-19 SafeCollect kits

Self-collection devices designed for ease of use and safety


Positive results from Pfizer’s Phase 3 trail comparing efficacy of abrocitinib and dupilumab
Drug Approval | September 01, 2021

Positive results from Pfizer’s Phase 3 trail comparing efficacy of abrocitinib and dupilumab

JADE DARE trial met co-primary and key secondary endpoints and demonstrated a safety profile consistent with previous studies for moderate to severe atopic dermatitis


SK Bioscience and GSK start Phase 3 trial of an adjuvanted COVID-19 vaccine candidate
Drug Approval | September 01, 2021

SK Bioscience and GSK start Phase 3 trial of an adjuvanted COVID-19 vaccine candidate

Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data. The global clinical trial will evaluate vaccine candidate GBP510 against the AZ/Oxford COVID-19 vaccine


Sun Pharma to commercialise Winlevi in the US and Canada
News | August 31, 2021

Sun Pharma to commercialise Winlevi in the US and Canada

Acne affects up to 50 million Americans annually. The last FDA approval of an acne drug with a new MOA occurred nearly 40 years ago


Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis
Biotech | August 31, 2021

Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis

Results reinforce the well-established safety profile of Dupixent - the first-ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old


Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test
Drug Approval | August 30, 2021

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test

The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit


Indian National Institute validates Livinguard’s face mask
Drug Approval | August 28, 2021

Indian National Institute validates Livinguard’s face mask

Textiles treated with the technology have also been proven to deactivate viruses, including SARS-CoV-2 (the virus that causes COVID-19).


European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo


U.S. FDA approves drug-free VNS system for stroke
Drug Approval | August 28, 2021

U.S. FDA approves drug-free VNS system for stroke

When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke


Japan approves AstraZeneca’s Forxiga for chronic kidney disease
Drug Approval | August 28, 2021

Japan approves AstraZeneca’s Forxiga for chronic kidney disease

Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options