Tirzepatide gained an FDA cardiovascular indication after SURPASS-CVOT showed noninferiority to dulaglutide in high-risk adults.
News|Slideshows|October 6, 2026
9 Drugs Approved for Primary Care: Q3 2026
Author(s)Sydney Jennings
Fact checked by: Abigail Brooks, MA
Catch up on the 9 FDA drug approvals most relevant to primary care, including new options for HIV-1 infection, narcolepsy, diabetes, pain management, and more.
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An oral PCSK9 inhibitor for hypercholesterolemia and a once-weekly basal insulin for type 2 diabetes were among the FDA approvals with direct relevance to primary care in the third quarter of 2026. The decisions also expanded options for ADHD, contraception, influenza prevention, HIV treatment, narcolepsy, and pain relief.
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The FDA has approved insulin efsitora alfa-gobe (Onswik) for adults with type 2 diabetes.
Finerenone wins FDA clearance for type 1 diabetes–related CKD, lowering albuminuria in FINE-ONE and opening a long-awaited treatment path.
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 approved bictegravir/lenacapavir for adults with suppressed HIV-1 and no known or suspected component resistance.
FDA expands dolutegravir dispersible tablets to children with HIV-1 weighing at least 2 kg, including eligible term newborns.
FDA has granted IDE approval for the STROKE-REWIRE pivotal trial evaluating NeuWire Medical's neurostimulation device for chronic ischemic stroke recovery.
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