News|Articles|September 2, 2025

HCPLive 5 Stories in Under 5: Week of 08/24

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Key Takeaways

The FDA accepted a priority review for omidubicel, a cell therapy for severe aplastic anemia, indicating its potential significance in treatment.
An updated REMS label for sparsentan in IgA nephropathy was approved, reducing monitoring requirements for patients.
Insufficient efficacy evidence led the FDA to issue a complete response letter for ONS-5010 in wet AMD.
New ACC guidelines recommend respiratory disease vaccination for adults with cardiovascular disease to enhance prevention and access.
Orforglipron demonstrated significant weight loss and glycemic control in phase 3 trials for adults with obesity or type 2 diabetes.

An audio recap of the top 5 stories in healthcare news from the week of 08/24-08/30.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 Healthcare Headlines for August 17-23, 2025:FDA Accepts Priority Review Application of Omidubicel for Severe Aplastic Anemia
The FDA accepted a priority review application for omidubicel, a cell therapy under investigation for severe aplastic anemia.

FDA Approves REMS Label Update for Sparsentan (Filspari) in IgA Nephropathy
The FDA approved an updated REMS label for sparsentan, easing monitoring requirements for patients with IgA nephropathy.

FDA Issues CRL to Outlook Therapeutics' ONS-5010 for the Treatment of Wet AMD
The FDA issued a complete response letter for ONS-5010 in wet AMD, citing insufficient efficacy evidence from the phase 3 program.

ACC Releases Respiratory Disease Vaccination Guidelines for Adults with Heart Disease
The ACC released new guidance recommending vaccination against respiratory infections for adults with cardiovascular disease to improve prevention and access.

Orforglipron Delivers Weight Loss, A1C Reductions in Phase 3 ATTAIN-2 Trial
Eli Lilly reported phase 3 results showing orforglipron improved weight and glycemic control in adults with obesity or overweight and type 2 diabetes.

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HCPLive 5 Stories in Under 5: Week of 08/24

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