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Faron Pharmaceuticals (AIM: FARN) a clinical stage biopharmaceutical company, announced the US Food and Drug Administration has approved the Investigational New Drug Application for Traumakine, the Company’s wholly-owned product for the treatment of Acute Respiratory Distress Syndrome, which is part of the regulatory process towards BLA submission. As quoted in the press release: Faron is …
Faron Pharmaceuticals (AIM: FARN) a clinical stage biopharmaceutical company, announced the US Food and Drug Administration has approved the Investigational New Drug Application for Traumakine, the Company’s wholly-owned product for the treatment of Acute Respiratory Distress Syndrome, which is part of the regulatory process towards BLA submission.
As quoted in the press release:
Faron is also planning to conduct a small open label study in the US for pharmacological purposes and the IND will allow opening of clinical activities in the US. This first US study will target Traumakine (drug product FP-1201-lyo) in moderate and severe ARDS patients, especially with end organ (kidney and liver) failures.