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Pharming announces FDA Acceptance for Review of Supplemental Biologics License Application for RUCONEST® for Prophylaxis of Hereditary Angioedema Attacks

Operational updates

Pharming Group N.V. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Pharming’s supplemental Biologics License Application (sBLA) for RUCONEST® [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE).

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Pharming Submits Supplemental Biologics License Application to FDA for RUCONEST® for Prophylaxis of Hereditary Angioedema Attacks

Operational updates

Pharming Group N.V. today announced that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (“FDA”) for RUCONEST® [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (“HAE”).

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