Xembify Receives Expanded Label for PI Patients
The U.S. Food and Drug Administration (FDA) has approved an expanded label for Grifols’ XEMBIFY (20% subcutaneous immune globulin [SCIG]) to include treatment-naïve patients with primary humoral immunodeficiencies (PI).
FDA Approves Additional Indication for Fibryga
Octapharma USA’s Fibryga (fibrinogen [human] lyophilized powder for reconstitution) has received U.S. Food and Drug Administration (FDA) approval for an additional indication: fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD).
FDA Approves Epinephrine Nasal Spray
The U.S. Food and Drug Administration (FDA) has approved the first needle-free alternative to the EpiPen.
Study Shows Vaccination Decision in IEI Patients Must Be Individualized
Inborn errors of immunity (IEI) increase morbidity and mortality risks, particularly from respiratory tract infections. Hence, vaccination becomes pivotal for IEI patients.
Immune Globulin and Prophylactic Antibiotics Provide Similar Efficacy in Treating Hypogammaglobulinemia Secondary to Hematological Malignancy
Immune globulin replacement and prophylactic antibiotics are commonly used to prevent infections in patients with secondary hypogammaglobulinemia due to hematological malignancies but have never been directly compared.
New Study to Examine COVID-19 Vaccines in People with Weakened Immune Systems
Researchers at the University of Wisconsin (UW) School of Medicine and Public Health are exploring the ideal vaccine booster strategy for immunosuppressed patients to protect those at higher risk of severe illness and complications from COVID-19 infection.
New Vaccine Could Lower ‘Bad’ Cholesterol by as Much as 30 Percent
A new vaccine currently in development can effectively and affordably lower levels of “bad’ cholesterol in the body, a health problem that affects almost two in five adults in the U.S.
CSL Behring Adds 4 and 5 Gram Vials of ZEMAIRA
CSL Behring’s ZEMAIRA (alpha1- proteinase inhibitor [human]) is now available in 4 gram and 5 gram vials.
World’s First Gene Therapies Approved to Treat Sickle Cell Disease
The U.S. Food and Drug Administration has approved two treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease in patients 12 years and older.
FDA Approves Repotrectinib for Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration has approved Bristol Myers Squibb’s repotrectinib (Augtryo) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
