The FDA has received reports of tranexamic acid injection being erroneously administered intrathecally in the perioperative setting instead of the intended intrathecal anesthetic (eg, bupivacaine injection) for neuraxial anesthesia.
Rilzabrutinib has been granted Fast Track designation for the treatment of immune thrombocytopenia.
This action was in response to an executive order issued on August 6, 2020 aimed at protecting the public against outbreaks of emerging diseases and chemical, biological, radiological, and nuclear threats.
The prospective, multinational, open-label, non-controlled phase 3 NuProtect study assessed the immunogenicity, efficacy and safety of Nuwiq in 105 previously untreated patients with severe hemophilia A.
Siklos is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in children with sickle cell anemia.
In expanded research, investigators studied the effects of therapeutic and prophylactic anticoagulation treatment in hospitalized patients with COVID-19.
Inadvertent administration may result in serious adverse events.
The Agency requested that the Company provide substantial evidence from its phase 3 study demonstrating durable effect using annualized bleeding rate.
Xyntha works by temporarily replacing the missing clotting factor VIII that is needed for effective hemostasis.
One nonfatal adverse event has been reported during the timeframe the affected product was distributed.
