The approval of Cabenuva was based on data from two phase 3 trials which included 1182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) prior to initiation.
The placebo-controlled BLAZE-2 trial included 965 adults who tested negative for SARS-CoV-2 at baseline (299 residents and 666 staff) in the primary analysis for assessing prevention.
The sBLA submissions were based on data from the CheckMate -649 and CheckMate -577 trials.
The approval was based on data from the double-blind, placebo-controlled phase 3 VICTORIA trial.
To date, there have been no reported cases of transfusion-transmitted coronavirus, including SARS-CoV-2.
The FDA has accepted for filing and granted Priority Review to narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
The approval was based on data from the open-label, active-controlled phase 3 ANDROMEDA study.
The approval was based on data from an open-label phase 1/2 trial in patients aged 1 to 21 years that included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least 1 systemic treatment.
Patients will be able to share information collected in the app with health care providers to provide a comprehensive assessment of the SCS or DRG therapy.
Ligelizumab is a high-affinity monoclonal anti-immunoglobulin E (IgE) antibody.
