InflaRx Receives Positive CHMP Opinion for GOHIBIC® (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome
15 nov. 2024 07h51 HE
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InflaRx N.V.
JENA, Germany, Nov. 15, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced...
InflaRx Announces Initiation of its Commitment Program for GOHIBIC®(vilobelimab) to Help Broaden Access for Eligible Patients
25 janv. 2024 07h30 HE
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InflaRx N.V.
InflaRx to cover costs of GOHIBIC for patients who are treated in line with its Emergency Use Authorization (EUA) but do not survive. InflaRx is determined to support broader access to GOHIBIC for...
InflaRx’s Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA)
30 août 2023 07h30 HE
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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 Announces Commercial Launch of Gohibic (vilobelimab) in the U.S. for the Treatment of Critically Ill COVID-19 Patients
21 juin 2023 07h00 HE
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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 Receives FDA Emergency Use Authorization for Gohibic (vilobelimab) for Treatment of Critically Ill COVID-19 Patients
04 avr. 2023 14h55 HE
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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 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
21 déc. 2022 07h30 HE
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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 Submits Request for Emergency Use Authorization to US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients
29 sept. 2022 07h30 HE
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InflaRx N.V.
Company also earns FDA Fast Track designation for vilobelimab to treat critically ill COVID-19 patientsEUA submission based on Phase III results in critically ill COVID-19 patients, recently published...