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Potential Treatment from ARCA for COVID-19 Receives Fast Track Designation
americanpharmaceuticalreview
December 09, 2020
ARCA biopharma announced the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of AB201 as a potential treatment for COVID-19.
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FDA grants COVID-19 treatment Fast Track designation
europeanpharmaceuticalreview
December 02, 2020
The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
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ARCA Biopharma’s AB201 for COVID-19 Gets Fast Track
contractpharma
November 24, 2020
ARCA biopharma, Inc., a company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, received Fast Track designation from the FDA for AB201 as a potential treatment for COVID-19.
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ARCA Announces IND Application Approval for Potential COVID-19 Treatment
americanpharmaceuticalreview
October 14, 2020
ARCA biopharma announced the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for AB201 (rNAPc2) as a potential treatment for patients hospitalized with COVID-19.
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ARCA gets FDA approval of IND for Covid-19 drug candidate AB201
pharmaceutical-business-review
October 10, 2020
ARCA biopharma said that its investigational new drug (IND) application for AB201 (rNAPc2) as a potential treatment for patients hospitalised with Covid-19 has been approved by the US Food and Drug Administration (FDA).
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ARCA Submits IND Application for AB201 as Potential COVID-19 Treatment
americanpharmaceuticalreview
September 27, 2020
ARCA biopharma has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of patients hospitalized with ...
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ARCA Submits IND for AB201 in COVID-19
contractpharma
September 22, 2020
AB201, a Phase IIb-ready recombinant protein aims to address the pathologies caused by viral infections from multiple aspects.
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ARCA biopharma submits IND application to US FDA for a potential COVID-19 treatment
expresspharma
September 22, 2020
Pending FDA feedback, ARCA anticipates initiating the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 in the fourth quarter of this year.
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ARCA Announces AB201 Development Program for COVID-19 Associated Coagulopathy
americanpharmaceuticalreview
June 04, 2020
ARCA biopharma announced a new development program to evaluate AB201 (rNAPc2), a potent, selective inhibitor of tissue factor (TF), as a potential treatment for COVID-19 associated coagulopathy (CAC) and the related inflammatory response.