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.
Hizentra Vials to Be Discontinued and Replaced with Prefilled Syringes
CSL Behring is discontinuing all sizes of Hizentra vials in the U.S. by the end of September 2024.
Selarsdi Approved as Biosimilar to Stelara to Treat Plaque Psoriasis and Psoriatic Arthritis
The U.S. Food and Drug Admini-stration has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.
Blood Test Predicts Multiple Sclerosis Years Before Symptoms Appear
Researchers at the University of California, San Francisco, have identified a specific pattern of autoantibodies in the blood that precedes the clinical onset of multiple sclerosis.
FDA Grants wilate Orphan Drug Exclusivity
The U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for Octapharma’s wilate, von Willebrand factor/coagulation factor VIII complex (human) lyophilized powder for solution for intravenous injection, for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years of age and older with von Willebrand disease (VWD).
How FDA Is Working to Accelerate Rare Disease Treatments
Through regulatory pathways and patient engagement, FDA is helping to advance treatment innovations for rare diseases.
Cryoprecipitate, Fibrinogen Concentrates and New Pathogen Reduced Cryo Product Vie for Use in Massive Hemorrhage
Does the shorter preparation time for fibrinogen concentrates make them a reasonable option in lieu of IFC in defined patient populations experiencing massive hemorrhage?
