The HCPFive: Top News for Healthcare Providers from the Week of 08/24

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration (FDA) Priority Review of omidubicel for severe aplastic anemia, the approval of an updated Risk Evaluation and Mitigation Strategy (REMS) label for sparsentan (Filspari) for IgA nephropathy (IgAN), a Complete Response Letter (CRL) issued to ONS-5010 for the treatment of wet age-related macular degeneration (AMD), new American College of Cardiology guidance on respiratory disease vaccines for adults with cardiovascular disease, and phase 3 ATTAIN-2 trial data for orforglipron in adults with obesity or overweight and type 2 diabetes.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of August 24, 2025—let’s jump in!

FDA Accepts Priority Review Application of Omidubicel for Severe Aplastic Anemia

On August 25, 2025, the FDA accepted the priority review application for Ayrmid’s omidubicel, an investigative cell therapy, for the treatment of severe aplastic anemia. With the acceptance, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 10, 2025.

FDA Approves REMS Label Update for Sparsentan (Filspari) in IgA Nephropathy

On August 27, 2025, Travere Therapeutics announced the FDA approval of an updated REMS labeling for sparsentan (Filspari) for the treatment of IgAN, reducing the frequency of liver function monitoring from monthly to every 3 months from the onset of treatment with sparsentan and removing the embryo-fetal toxicity monitoring requirement.

FDA Issues CRL to Outlook Therapeutics' ONS-5010 for the Treatment of Wet AMD

On August 28, 2025, the FDA issued a CRL to Outlook Therapeutics' Biologics License Application for ONS-5010 for the treatment of wet AMD, citing the agent’s failure to achieve the primary efficacy endpoint in the phase 3 NORSE EIGHT trial. With the CRL, the FDA suggested the Company submit confirmatory evidence of efficacy to support the next application. The Agency did, however, reiterate the achievement of NORSE TWO's primary effectiveness endpoint.

ACC Releases Respiratory Disease Vaccination Guidelines for Adults with Heart Disease

On August 26, 2025, the American College of Cardiology released Concise Clinical Guidance recommending vaccines to protect adults with cardiovascular disease against a variety of respiratory diseases, including COVID-19, respiratory syncytial virus (RSV), and influenza. The guidelines also aim to improve access to vaccines, effectively circumventing financial barriers to access, providing accurate and practical education, and assuaging concerns that give rise to vaccine hesitancy and resistance.

Orforglipron Delivers Weight Loss, A1C Reductions in Phase 3 ATTAIN-2 Trial

On August 26, 2025, Eli Lilly and Company announced positive topline results from the phase 3 ATTAIN-2 trial evaluating orforglipron, an investigational oral GLP-1 receptor agonist, in adults with obesity or overweight and type 2 diabetes. In the trial, all 3 doses of orforglipron met the primary and all key secondary endpoints, delivering significant weight loss, meaningful A1C reductions, and improvements in cardiometabolic risk factors at 72 weeks. With the completion of ATTAIN-2, Lilly now has the full clinical data package required to initiate global regulatory submissions for orforglipron.