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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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