FDA Approves Dupixent for Chronic Obstructive Pulmonary Disease
The U.S. Food and Drug Administration (FDA) has expanded its approval of Dupixent to chronic obstructive pulmonary disease (COPD).
Updated COVID Vaccines Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved and granted emergency use authorization for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2.
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.
Update on Treating Neutropenia
While neutropenia can be a life-threatening condition, physicians have many tools to treat it.
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.
Fresenius Kabi’s Tyenne, a Biosimilar of Actemra, Is Approved to Treat Autoimmune Diseases
The U.S. Food and Drug Administration has approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), to treat multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis.
