The U.S. Food and Drug Administration (FDA) has approved the first needle-free alternative to the EpiPen.
FDA has approved Octapharma USA's Fibryga (fibrinogen [human] lyophilized powder for reconstitution) for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency.
CMS issued a proposed rule that announces and solicits public comments on proposed policy changes for Medicare payments on or after Jan. 1, 2025.
FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand.
SAMHSA released the results of the 2023 National Survey on Drug Use and Health (NSDUH), which shows how people living in the United States reported their experience with mental health conditions, substance use and pursuit of treatment.
A meta-analysis and systematic review compared the efficacy of corticosteroids (CS) alone against CS combined with intravenous immune globulin (IVIG) or CS combined with plasmapheresis (PP) in patients with steroid-resistant optic neuritis.
In a Phase III, double-blind, three-way crossover trial, sebetralstat given on-demand for treatment of hereditary angioedema (HAE) attacks was shown to result in faster times to the start of symptom relief, reduction in attack severity and complete attack resolution than placebo treatment.
A newly discovered COVID strain known as XEC continues to spread rapidly across multiple countries, including the U.S.
The U.S. Food and Drug Administration has granted full approval to Travere Therapeutics’ Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy.
A study by researchers at Washington University School of Medicine in St. Louis indicates next-generation vaccines that target a virus’s points of entry — the nose and mouth — may be able to contain the spread of respiratory infections and prevent transmission.
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).
The U.S. Food and Drug Administration has granted breakthrough device designation to Revita System (Fractyl Health Inc.) for the maintenance of weight loss after discontinuation of glucagon-like peptide-1 medications.