Hey readers! Here's something you don't see often in diabetes care: an insulin you inhale instead of inject, and it just cleared a big regulatory hurdle for kids. That's the headline this week, but we've also got a fresh NovoLog biosimilar, encouraging GLP-1 safety data, and a look at why beta cells fail in the first place. Let's dig in.
💨 Afrezza clears the FDA for children
MNKD Stock Jumps On Receiving FDA Approval For Afrezza To Treat Diabetes In Children The FDA approved expanded use of MannKind's Afrezza Inhalation Powder for children and adolescents aged 6 and older living with either type 1 or type 2 diabetes.
- Stocktwits
This matters because mealtime dosing is one of the hardest parts of managing T1D in kids, whose eating, snacking, and activity patterns rarely follow a schedule. Afrezza uses MannKind's Technosphere technology to deliver insulin rapidly into the bloodstream through a portable inhaler, and it's dosed at the start of a meal. For families juggling injections or pump sites at school and sports, having a needle-free rapid option on the table is genuinely useful.
The approval rests on the Phase 3 INHALE-1 study, a 26-week open-label randomized trial that compared Afrezza plus basal insulin against multiple daily injections of rapid-acting analog insulin. Per the report, Afrezza met its primary endpoint of noninferiority for HbA1c changes versus injections, with the results published in Diabetes Care.
"Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary. With its rapid onset and dosing at the start of a meal, Afrezza may help clinicians better match insulin therapy to how children and families live day to day." - Desmond Schatz, professor of pediatrics at the University of Florida College of Medicine
A couple of details worth flagging: the article notes pediatric patients in the inhaled group reported higher satisfaction and experienced less weight gain, and that eligible patients can access the drug for $35 or less per month. As always, inhaled insulin isn't right for everyone, and pediatric dosing decisions belong with your care team. But expanding options for kids who've historically had only injections or pumps is a welcome step.
💉 A new rapid-acting insulin lands
Staying on the theme of mealtime insulin, the injectable side got a new player this week too.
FDA Approves Garzulys as Third Biosimilar to NovoLog The FDA approved Garzulys (insulin aspart-fsan), a rapid-acting insulin analog biosimilar to NovoLog, to improve glycemic control in adults and pediatric patients with diabetes.
- Drug Topics
Garzulys is available as a U-100 vial and a prefilled pen, and it's cleared for subcutaneous injection, pump (continuous subcutaneous insulin infusion), and intravenous use. One important nuance: it's approved as a biosimilar but "not interchangeable," so a pharmacist can't automatically swap it for NovoLog without a prescriber's say-so. It becomes the third NovoLog biosimilar on the market, following Merilog (approved February 14, 2025) and Kirsty (approved July 15, 2025).
Meitheal Pharmaceuticals Wins FDA Approval for Garzulys Insulin Biosimilar covers the commercial side: Emerge Bioscience holds the approved Biologics License Application, while Meitheal is the U.S. regulatory agent with exclusive commercialization rights.
"We are making deliberate, long-term investments in the regulatory expertise, commercial infrastructure and strategic partnerships needed to expand patient access to high-quality biologic treatment options." - Tom Shea, Meitheal CEO
More rapid-acting options generally means more competition, and for insulin that's a good thing for access. Standard cautions apply: Garzulys is contraindicated during hypoglycemia and in anyone with hypersensitivity to its ingredients.
🛡️ Rethinking the disease itself
Mealtime insulin manages symptoms. A growing pipeline aims further upstream, at the autoimmune process that causes T1D in the first place.
Breakthrough Drug Teplizumab: Delaying Type 1 Diabetes Onset on the NHS Teplizumab is now available on the NHS in England and Wales, where it's used to delay the onset of type 1 diabetes symptoms by up to three years in at-risk children and young people.
- lions103n.org
"Teplizumab, a drug that has been described as 'genuinely exciting' by the NHS medicines body, is now available on the NHS in England and Wales."
Three extra years before lifelong insulin is a meaningful window for a family, and the article frames teplizumab as an early step in a broader set of immunotherapies funded by the charity Breakthrough T1D, with longer-term hopes for personalized combinations.
FDA Approves TZIELD: A Milestone for Type 1 Diabetes Treatment covers the related U.S. story, describing TZIELD as a disease-modifying therapy approved to delay the decline in endogenous insulin production in children aged eight to 17 recently diagnosed with stage 3 type 1 diabetes.
"TZIELD is a disease-modifying therapy, which means it has the potential to alter the course of type 1 diabetes."
TZIELD is a CD3-directed monoclonal antibody that acts on immune cells, and the article notes MacroGenics received a milestone payment from Sanofi tied to the approval. The takeaway: for the first time, the conversation is shifting from managing T1D to slowing its progression.
🔬 Research worth watching
GLP-1s in Type 1 Diabetes: No Link to Higher DKA A retrospective, single-center study at Loma Linda University Medical Center followed 7,377 adults with T1D for a year and found no DKA or pancreatitis among the 255 GLP-1 users, who also had a lower hospitalization rate (7.45% vs 13.11%). Given the long-standing worry that GLP-1s could trigger DKA in T1D, this is reassuring, though the authors stress individualized insulin dose adjustment and point to Eli Lilly's SURPASS-T1D as the trial to confirm it.
The Hidden Protein Crisis: What Really Causes Insulin Cells to Fail A June 2026 PNAS study in mice found the chaperone protein BiP needs a partner, p58IPK, to keep proinsulin folding correctly; without it, misfolded proinsulin builds up and insulin output drops. As the lead author put it: "BiP cannot just go it alone in maintaining the proper folding of proinsulin." It's a possible early-intervention target rather than symptom management.
Alignment-free CNN classification of glycemic states from breath spectra In a ten-person proof of concept, a neural network classified fasting, postprandial, and hypoglycemic states from exhaled breath with 86.6% mean balanced accuracy, flagging markers like acetone and isoprene. Early days and a tiny cohort, but a non-invasive complement to glucose monitoring is an appealing direction.
🩺 On the device and pipeline front
Medtronic launches Simplera Sync Sensor in Korea The all-in-one disposable CGM cuts insertion to two steps, drops routine fingerstick calibration, and works with existing MiniMed 780G pumps via a software update. Medtronic cites a real-world study of 8,019 U.S. users reporting 91% nighttime Time in Range.
Aqua Medical treats first U.S. patient with endoscopic PIMA therapy An investigational through-the-scope procedure for type 2 diabetes resurfaces a segment of the small intestine to restore metabolic signaling; the first U.S. patient was treated July 28, 2026 at UNC Health, with 66 patients previously treated outside the U.S.
Jeil Pharmaceutical's JP-2266 posts positive Phase 2 data The oral dual SGLT-1/SGLT-2 inhibitor cut HbA1c by roughly 0.94 to 0.97 percentage points versus placebo over 12 weeks in 156 type 2 patients, with Phase 3 still needed.
That's the roundup. Whether you're weighing a needle-free mealtime option, tracking the immunotherapies trying to change the disease course, or just staying current, we hope this gave you something concrete to take to your next appointment. Take care of yourselves.