Inhaled Insulin, Afrezza, Expanded to Include Children and Adolescents with Diabetes
On May 29, 2026, the US Food and Drug Administration (FDA) expanded MannKind Corporation’s Afrezza® (insulin human) inhalation powder for the treatment of diabetes mellitus type 1 and type 2 in children and adolescents aged six years and older. Initially approved for adults only, Afrezza is a rapid-acting inhaled human insulin indicated for improving glycemic control and now represents the first inhaled mealtime insulin option available for pediatric patients. More than 350,000 children and adolescents in the US are living with diabetes, most of whom have type 1 disease requiring lifelong insulin therapy. Afrezza is an ultra-rapid-acting inhaled insulin administered at the start of meals that is designed to mimic physiologic insulin response, utilizing the Technosphere® dry-powder delivery system to provide a needle-free alternative to multiple daily injections. The recommended dose involves using the inhaler device to administer the insulin at the beginning of meals, with titration based on glycemic response. Afrezza carries a risk of acute bronchospasm in patients with chronic lung disease, including asthma and chronic obstructive pulmonary disease (COPD), and is contraindicated in these populations. Use requires pulmonary function assessment before initiation to assess for underlying lung disease. Here is the updated prescribing information.
FDA Approves First Oral Antiviral for Post-Exposure Prevention of COVID-19
The FDA approved Shionogi’s Xocova® (ensitrelvir) tablets for oral use for the post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents aged 12 years and older following contact with an infected individual on June 1, 2026. Xocova is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease inhibitor and works by blocking viral replication during the early phase after exposure, allowing intervention before symptom onset. This is the first oral antiviral option for preventing symptomatic COVID-19 after exposure. Approval was based on a 67% relative reduction in the risk of symptomatic COVID-19 through day ten compared with placebo (2.9% vs 9.0%). The recommended dose is a five-day oral course consisting of 375mg (three 125mg tablets) on day one, followed by 125mg once daily on days two through five. Therapy should be initiated as soon as possible and within 72 hours of exposure. Launch timing and pricing have not been specified. Here is the prescribing information.
New IV Antibiotic Zaynich Approved for Multidrug-Resistant Complicated UTIs
On May 29, 2026, the FDA approved Wockhardt’s Zaynich™ (cefepime and zidebactam) for the treatment of adult patients who have complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. This combination pairs a fourth-generation cephalosporin, cefepime, with a novel β-lactam enhancer, zidebactam, that targets multiple penicillin-binding proteins, allowing for synergistic activity against multidrug-resistant organisms. Approval was based on results from the phase III ENHANCE-1 trial, in which Zaynich demonstrated superior combined clinical cure and microbiologic response versus meropenem (89.0% vs 68.4%) and was generally well tolerated. The recommended dose is 3g (2g cefepime/1g zidebactam) administered intravenously (IV) every eight hours over one hour for seven to ten days, with renal dose adjustments as needed. Over 2.8 million antimicrobial-resistant infections occur annually in the US, contributing to over 35,000 deaths. Zaynich should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria to help limit the development of drug-resistant organisms and preserve its effectiveness. Common adverse reactions include diarrhea, hypertension, headache and hypokalemia. Prescribing information is here.
Trimbow Triple Inhaler Approved for Asthma
Chiesi USA’s Trimbow® (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate) inhalation aerosol was approved on May 18, 2026, for the maintenance treatment of asthma in adults. Trimbow is a triple therapy single inhaler, combining beclomethasone dipropionate, an inhaled corticosteroid (ICS); formoterol fumarate, a long-acting beta-agonist (LABA); and glycopyrrolate, an anticholinergic, in one pressurized metered‑dose inhaler. Approval was supported by statistically significant improvements in lung function versus dual therapy (ICS/LABA) and reductions in exacerbations in select analyses. Trimbow showed a safety profile comparable to ICS/LABA therapy, with common adverse events including respiratory infections, dysphonia, hypertension and musculoskeletal symptoms. It is administered twice daily via a pressurized metered‑dose inhaler (pMDI) and is available in two fixed‑dose strengths (86mcg/4.9mcg/10.6mcg and 172mcg/4.9mcg/10.6mcg). Here is the prescribing information.
New Nilotinib Formulation Approved, Allowing Concomitant Use With Acid-Reducing Agents
On June 2, 2026, the FDA approved another new nilotinib formulation, Cycle Pharmaceuticals’ Cavhanza™ (nilotinib) orally disintegrating tablets (ODT). Approved for the treatment of adult patients who have Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML), it includes newly diagnosed chronic-phase disease and chronic or accelerated phase disease with resistance or intolerance to prior therapy, including imatinib. Originally approved in 2007, Tasigna® (nilotinib – Novartis) is a tyrosine kinase inhibitor (TKI) that carries a boxed warning to avoid food two hours prior to and one hour after taking each twice-daily capsule, as food causes increased absorption and therefore increases the risk of significant prolongation of the QT interval. Azurity Pharmaceuticals nilotinib formulation, Danziten™, was approved by the FDA in 2024 and can also be taken without regard to food, however, it requires avoidance of concomitant proton pump inhibitors (PPIs), and if acid-reducing therapy is needed, H₂ receptor antagonists (H₂RAs) should be administered approximately ten hours before or two hours after Danziten dosing. It is estimated that 25% of patients on nilotinib are prescribed PPIs or H₂RAs. Cavhanza’s ElectroNanoSpray™-enabled ODT improves solubility and dissolution, allowing maintained bioavailability with concomitant use of acid-reducing agents without timing restrictions and eliminating food-related dosing limitations. The recommended dosing is 120mg orally twice daily for newly diagnosed chronic-phase disease and 160mg twice daily for resistant or intolerant disease. Like other nilotinib products, Cavhanza has boxed warnings for QT prolongation and sudden death and requires ECG monitoring and avoidance in patients who have electrolyte abnormalities or concomitant QT-prolonging agents. Cycle Pharmaceuticals indicated that the launch is expected soon. Full prescribing information is available here.
Istodax Generic, Romidepsin, Reenters the Market
The FDA approved Amneal Pharmaceuticals’ romidepsin injection solution 27.5mg/5.5mL on June 4, 2026, as a ready‑to‑use formulation for the treatment of cutaneous T‑cell lymphoma in adult patients who have received at least one prior systemic therapy. Romidepsin, a histone deacetylase inhibitor, enters an established oncology market following the withdrawal of earlier solution formulations. This single‑dose injectable vial eliminates the need for reconstitution, offering an alternative to previously available lyophilized powder formulations that require preparation before administration. The product received Competitive Generic Therapy designation, providing 180 days of market exclusivity. According to IQVIA, US annual sales for romidepsin products were approximately $78 million for the 12 months ending April 2026. Here is the prescribing information.
FDA Approves Ranluspec, Fourth Interchangeable Lucentis Biosimilar
On June 5, 2026, the FDA approved Lupin’s Ranluspec™ (ranibizumab-hkdz) injection as an interchangeable biosimilar to Genentech’s Lucentis® for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization in adults. It will be available in 0.3mg (0.05mL of 6mg/mL) and 0.5mg (0.05mL of 10mg/mL) vials and prefilled syringe formulations. This is the fourth interchangeable biosimilar to Lucentis, following Byooviz® (ranibizumab-nuna – Samsung Bioepis/Biogen), Cimerli® (ranibizumab-ranq – Sandoz), and Nufymco™ (ranibizumab-leyk – Zydus), although only Byooviz and Cimerli have launched. Ranluspec will be the first prefilled syringe formulation available. Launch timing and pricing details were not disclosed.
Recall
Dexcom Recalls Stolen Sensors
On May 26, 2026, Dexcom, Inc. initiated an urgent medical device correction involving select Dexcom G7® continuous glucose monitoring (CGM) sensors after identifying that two lots originally designated as scrap and intended for destruction were stolen during the destruction process and then sold by third parties. The issue primarily affects the United States, and Dexcom traced the distribution of the stolen product to Pharmsource, LLC, which is not an authorized Dexcom distributor. The affected product was scrapped because it did not meet Dexcom quality standards. Specifically, one lot was associated with insufficient sterilization, and the other had an elevated internal testing failure rate. Dexcom stated that unknown storage and handling conditions during unauthorized distribution may create additional risk. Additional recall information and serial number verification are available at Dexcom’s theft-check site www.dexcom.com/theft-check. Dexcom also provides a list of authorized suppliers at www.dexcom.com/dexcom-suppliers. Dexcom G7 is FDA cleared for the management of diabetes mellitus in persons aged 2 years or older, indicated for CGM to replace fingerstick blood glucose testing for diabetes treatment decisions and to provide alerts for hypoglycemia and hyperglycemia. To read more details about the recall, see here.
Omnipod Pods Recalled
On May 26, 2026, Insulet Corporation initiated a voluntary recall of specific lots of Omnipod® 5 pods, Omnipod DASH® pods, and Omnipod® Insulin Management System (Omnipod Eros) pods. The recall was prompted by a potential device malfunction that may result in interruption or under-delivery of insulin, including medically significant outcomes such as hyperglycemia and risk of diabetic ketoacidosis (DKA). Omnipod systems are FDA-cleared for the management of diabetes mellitus requiring continuous subcutaneous (SC) insulin infusion. Patients can check whether their pod lots are affected here. The FDA recall notice is available here.
Huons Recalls Lidocaine Injection and Bupivacaine in Dextrose Injection
On May 27, 2025, Huons Co. Ltd. initiated voluntary recalls of lidocaine HCl injection and bupivacaine HCl in dextrose injection for all lots. The recall was prompted by quality issues identified during a recent FDA manufacturing facility inspection, with a potential health hazard, including a small number of reports of drug ineffectiveness. Lidocaine HCl injection is approved to produce local or regional anesthesia, and bupivacaine HCl in dextrose injection is FDA‑approved for spinal anesthesia. This recall represents an expansion impacting additional re-packagers not identified in prior recalls reported in April 2026. To read about the latest recall, please see here.