Finerenone wins FDA clearance for type 1 diabetes–related CKD, lowering albuminuria in FINE-ONE and opening a long-awaited treatment path.
News|Articles|August 4, 2026
5 FDA Decisions for Primary Care to Know from July 2026
Author(s)Sydney Jennings
Fact checked by: Abigail Brooks, MA
Recent FDA actions include approvals and clearances in lipid management, CRC screening, contraception, vaginitis testing, and Alzheimer psychosis.
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In July, the
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The US FDA cleared a novel insulin patch pump that can be used for up to 3 days with an additional 12-hour grace period in persons with diabetes.
The FDA accepted Organon’s MIUDELLA supplemental application, but the proposed change, supporting data, and review timeline remain undisclosed.
FDA awarded DT120 Breakthrough Therapy designation for MDD based on phase 3 data showing rapid, sustained improvement after one 100 μg dose.
Recent FDA actions include updates in HIV, influenza, narcolepsy, type 2 diabetes, and RSV prevention in high-risk children.
FDA approved bictegravir/lenacapavir for adults with suppressed HIV-1 and no known or suspected component resistance.
Tirzepatide gained an FDA cardiovascular indication after SURPASS-CVOT showed noninferiority to dulaglutide in high-risk adults.
FDA expands dolutegravir dispersible tablets to children with HIV-1 weighing at least 2 kg, including eligible term newborns.
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