Anavip Approval Expanded to Include Copperhead, Cottonmouth/Water Moccasin Envenomations
Anavip contains venom-specific F(ab’)2 fragments of immunoglobulin G that bind and neutralize venom toxins.
Bleeding Disorders
Pediatric Data Added to Octaplas, Fibryga Labeling
The updated labeling for Octaplas and fibryga includes new pediatric data.
Antidepressants Not Tied to Increased Intracerebral Hemorrhage Risk
Selective serotonin reuptake inhibitors are not associated with higher risk for intracerebral hemorrhage
EndoClot PHS Approved to Control Bleeding During GI Procedures
EndoClot PHS is a single-use device consisting of a starch-based powder hemostat to control bleeding in the GI tract.
Patient With Gaucher Disease and ITP Effectively Treated With Eltrombopag
The patient, who was initially diagnosed with Gaucher disease type 1 during her first pregnancy 20 years prior, presented with bleeding, hematomas, and thrombocytopenia, in addition to hepatomegaly, splenomegaly, and bone marrow infiltration.
FDA: Risk of Inadvertent Intrathecal Administration of Tranexamic Acid Injection
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 Fast Tracked for Immune Thrombocytopenia
Rilzabrutinib has been granted Fast Track designation for the treatment of immune thrombocytopenia.
FDA Identifies Most Needed Meds to Address Urgent Medical Conditions
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.
Immunogenicity Data Added to Nuwiq Labeling
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 Now Available in 100mg Scored Tablets
Siklos is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in children with sickle cell anemia.
