FDA Approves Additional Indication for Fibryga

FDA has approved Octapharma USA’s Fibryga (fibrinogen [human] lyophilized powder for reconstitution) for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency.

CMS Proposes Payment Cut for Physicians

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 Modernizes Informed Consent Guidance, Aligning with Common Rule Changes

FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing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 Releases Annual National Survey on Drug Use and Health

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.

Addition of IVIG May Be Superior to Addition of Plasmapheresis in Corticosteroid-Resistant Optic Neuritis: Systemic Review

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.

Investigational Plasma Kallikrein Inhibitor (Sebetralstat) Reduces Time to Relief from Hereditary Angioedema Attacks

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.

Scientists Develop $25 Nasal Spray That Is 99% Effective Against Colds, Flu and COVID-19

Scientists at Harvard Medical School have developed a simple nasal spray, made of harmless ingredients, that can protect people against flu, colds and COVID-19 with near-100 percent success, and it costs just $25.

First Nasal Self-Administered Flu Vaccine Approved by FDA

The first influenza nasal spray vaccine that can be self-administered has been approved by the U.S. Food and Drug Administration (FDA).

CDC Identifies New COVID Strain Known as XEC

A newly discovered COVID strain known as XEC continues to spread rapidly across multiple countries, including the U.S.

FDA Approves Filspari for Rare Kidney Disease IgA Nephropathy

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.