InflaRx’s Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA)
August 30, 2023 07:30 ET
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InflaRx N.V.
MAA for vilobelimab was submitted in JulyMAA has been validated by EMA and is now under reviewRegulatory submission based on pivotal data from PANAMO Phase III trialCompany announces attendance at...
InflaRx Reports Second Quarter 2023 Financial Results & Operating Update
August 10, 2023 07:30 ET
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InflaRx N.V.
• Quarter highlighted by the Emergency Use Authorization (EUA) and commercial launch of Gohibic (vilobelimab) in the United States • Oral C5aR inhibitor INF904 progressing in...
InflaRx Appoints Dr. Camilla Chong as Chief Medical Officer
June 28, 2023 07:30 ET
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InflaRx N.V.
Camilla Chong, M.D., joins the team with 25 years of experience in the global pharmaceutical industry in drug developmentDr. Chong to lead clinical development of InflaRx’s portfolio of C5a/C5aR...
InflaRx Announces Commercial Launch of Gohibic (vilobelimab) in the U.S. for the Treatment of Critically Ill COVID-19 Patients
June 21, 2023 07:00 ET
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InflaRx N.V.
Gohibic is now commercially available for hospitals in the U.S.Gohibic can be used under an Emergency Use Authorization (EUA) granted by the FDA for treatment of certain critically ill COVID-19...
InflaRx Reports First Quarter 2023 Financial and Operating Results and Provides Business Update
May 11, 2023 07:30 ET
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InflaRx N.V.
Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) for Gohibic (vilobelimab) for treatment of critically ill COVID-19 patientsGohibic planned to be available to...
InflaRx Receives FDA Emergency Use Authorization for Gohibic (vilobelimab) for Treatment of Critically Ill COVID-19 Patients
April 04, 2023 14:55 ET
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InflaRx N.V.
Vilobelimab is the first authorized drug to control complement factor C5a, a protein that plays an important and often harmful role in the body's immune responseFDA granted EUA based on Phase III...
InflaRx Reports Full Year 2022 Financial and Operating Results
March 22, 2023 07:30 ET
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InflaRx N.V.
Major progress in development of vilobelimab Phase III study in PG announced following detailed feedback and recommendations from the U.S. Food and Drug Administration (FDA); clinical trial protocol...
InflaRx Provides Update on Planned Phase III Study Design in Pyoderma Gangrenosum with Vilobelimab and Status of its EUA Application in Critically Ill COVID-19 Patients
January 05, 2023 07:30 ET
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InflaRx N.V.
Multi-national, randomized, controlled adaptive Phase III design for vilobelimab in ulcerative pyoderma gangrenosum (PG) Trial size to be adapted upon interim analysis with planned total patient...
InflaRx Announces Amendment of Co-Development Agreement and Additional Equity Investment by Staidson in Connection with Regulatory Filing in China for Anti-C5a-Antibody for Treatment of COVID-19
December 21, 2022 07:30 ET
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InflaRx N.V.
InflaRx will provide access to certain clinical, manufacturing and regulatory documentation for vilobelimab to facilitate STS’s regulatory filings in ChinaSTS plans to request regulatory approval in...
InflaRx Initiates First-in-Human Study with Small Molecule C5aR Inhibitor INF904
November 09, 2022 07:40 ET
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InflaRx N.V.
Randomized, double-blind, placebo-controlled Phase I trial of orally administered complement inhibitor INF904 initiatedStudy designed as single ascending dose to determine safety, tolerability and...