FDA Approves Celltrion’s Zymfentra to Treat Ulcerative Colitis and Crohn’s Disease
The U.S. Food and Drug Administration (FDA) has approved Celltrion’s Zymfentra, a subcutaneous injection formulation of its infliximab Remsina, for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn’s disease following treatment with an infliximab administered intravenously.
FDA Approves Wezlana, First Interchangeable Biosimilar to Stelara
The U.S. Food and Drug Administration (FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara for adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; and moderately to severely active ulcerative colitis.
HHS Awards $45 Million in Grants to Expand Access to Care for People with Long COVID
The U.S. Department of Health and Human Services announced nine grant awards $1 million each for up to five years to support existing multidisciplinary Long COVID clinics across the country.
Evidence-Based Teen Pregnancy Prevention Programs Receive HHS Awards
The U.S. Department of Health and Human Services (HHS) announced approximately $23 million in funding to foster innovation, provide new research and expand the evidence to support and advance equity in the Teen Pregnancy Prevention program.
First Drugs Selected for Medicare Drug Price Negotiation
The U.S. Department of Health and Human Services announced the first 10 drugs covered under Medicare Part D selected for negotiation as part of the Inflation Reduction Act.
OCR Issues Resources to Educate Patients about Telehealth and the Privacy and Security of Protected Health Information
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has issued two resource documents to help explain to patients the privacy and security risks to their protected health information when using telehealth services and ways to reduce these risks.
New mRNA-Based Therapy Effective in Treating Melanoma in Mouse Models
Investigators at the Icahn School of Medicine at Mount Sinai have designed an RNA-based strategy to activate dendritic cells, which play a key role in immune response, that eradicated tumors and prevented their recurrence in mouse models of melanoma.
Combination of IVIG and Corticosteroids Superior to Respective Monotherapies for Treatment of Relapsed ITP in Adults
The combination of intravenous immune globulin (IVIG) and corticosteroids is a more efficient and rapid treatment for relapsed immune thrombocytopenic purpura (ITP) in adults compared with the use of either therapy alone.
Early Albumin Administration May Reduce Mortality in Septic Shock and ARDS: Retrospective MIMIC III Database Study
A study has found that early albumin administration in septic shock patients with ARDS was independently associated with a reduction in 28-day mortality.
FDA Approves Antibody to Protect Infants Against RSV
The U.S. Food and Drug Administration (FDA) has approved nirsevimab to protect newborns from respiratory syncytial virus (RSV).
