FDA Approves Dupixent for Chronic Obstructive Pulmonary Disease
The U.S. Food and Drug Administration has expanded its approval of Dupixent to chronic obstructive pulmonary disease (COPD).
FDA Approves New Treatment for Hemophelia A and B
The U.S. Food and Drug Administration (FDA) approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies).
FDA Approves First Over-the-Counter Combo Flu and COVID Test Outside of Emergency Use
The U.S. Food and Drug Administration (FDA) has authorized the first over-the-counter combination COVID-19 and influenza test, the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, outside of emergency use.
Updated COVID Vaccines Approved by FDA
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 SARSCoV-2.
HHS Announces Price Cuts for 10 Medicare Drugs
The U.S. Department of Health and Human Services (HHS) has negotiated lower prices for 10 of the most expensive and widely used drugs covered under Medicare, which is expected to save the Medicare program $6 billion in the first year and reduce out-of-pocket costs for beneficiaries by $1.5 billion.
FDA Approves Epinephrine Nasal Spray
The U.S. Food and Drug Administration (FDA) has approved the first needle-free alternative to the EpiPen.
mRNA Cancer Therapy Boosts Immune Response
An investigational, individualized neoantigen therapy, with personalized encoded mRNA, has demonstrated potential to enable patients’ immune systems to target cells that cause cancer.
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FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing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.
