Salix Pharmaceuticals, Ltd. and Pharming Group NV announced that the FDA has approved Ruconest (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg...
Santarus, Inc. and Pharming Group NV have announced the submission of a Biologics License Application (BLA) to the FDA to...
A pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug Ruconest (recombinant human C1...
Pharming has received a Complete Response Letter (CRL) from the FDA regarding the supplemental Biologics License Application (sBLA) for Ruconest...
Pharming Group has announced that following the positive opinion of the Committee for Medicinal Products for Human Use, the European...
Pharming Group has announced that following evaluation of a dossier submitted by the Company earlier this year, the Committee for...
Ruconest is indicated for treatment of acute angioedema attacks in adults, adolescents, and children (aged 2 years and above) with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.