Prometic Life Sciences Inc. has announced that it has completed the filing of its plasminogen Biologics License Application (�BLA�) with...
Prometic Life Sciences announced that the FDA has accepted its Biologics License Application (BLA) for Ryplazim (plasminogen replacement therapy) having...
Liminal BioSciences Inc. a clinical-stage biopharmaceutical company, announced that the FDA has notified the Company that it has extended the review period for the Biologics License Application ("BLA") for Ryplazim (plasminogen), or Ryplazim, for the treatment of clinical signs and symptoms associated with congenital plasminogen deficiency.
Metalyse is indicated in adults for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms.
Liminal BioSciences Inc. announced that the FDA has approved Ryplazim (plasminogen, human-tvmh) for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia) through its subsidiary, Prometic Biotherapeutics Inc., holder of the biological license application (“BLA”) for Ryplazim. With this approval, Ryplazim becomes the first FDA approved therapy for this rare genetic disorder.
ProMetic Life Sciences Inc.has announced that its pivotal Phase II/III clinical trial in patients with plasminogen deficiency has met its...
Intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA) for acute ischemic stroke (AIS) is contraindicated in patient taking either Factor Xa inhibitors or direct thrombin inhibitors.
Swedish Orphan Biovitrum AB (publ) (Sobi) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of Kineret (anakinra) for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) 6 ng/ml.
Liminal BioSciences Inc. announced that the company, through its U.S. subsidiary Prometic Biotherapeutics Inc., has filed a resubmission of the Biologics License Application (BLA) for Ryplazim (plasminogen) with the FDA for the treatment of congenital plasminogen deficiency (C-PLGD).