FDA Approves Keytruda–Welireg Combination for High-Risk Adjuvant Renal Cell Carcinoma
On June 12, 2026, the US Food and Drug Administration (FDA) approved Merck’s Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Welireg® (belzutifan – Merck) for the adjuvant treatment of adults who have renal cell carcinoma with a clear cell component at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of all or part of the kidney), with or without resection of metastatic lesions. Adjuvant Keytruda monotherapy remains an established standard of care, and this newly approved combination of Keytruda, a programmed death-(PD)-1 inhibitor, and Welireg, a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, provides dual pathway targeting to reduce tumor recurrence risk. Approval was based on a statistically significant improvement in disease-free survival with a 28% reduction in the risk of recurrence, metastasis, or death compared with Keytruda plus placebo, with estimated 24-month disease-free survival rates of approximately 81% versus 74%, respectively. The recommended dose is Welireg 120mg orally once daily in combination with Keytruda administered intravenously (IV) every three or six weeks or Keytruda Qlex administered subcutaneously (SC) every three or six weeks for up to 12 months. Wellireg’s prescribing information can be found here.
Truqap Combination Approved for PTEN-Deficient Metastatic Prostate Cancer
The FDA approved AstraZeneca’s Truqap® (capivasertib), in combination with abiraterone acetate and prednisone on June 12, 2026, for the treatment of adult patients who have PTEN-deficient metastatic androgen pathway modulation–naïve or -sensitive prostate cancer, as identified by an FDA-authorized test. Initially approved for breast cancer, this new indication marks the first targeted treatment option for this molecularly defined population, with eligible patients identified using the FDA-approved VENTANA PTEN RxDx Assay (Ventana Medical Systems/Roche Diagnostics) as a companion diagnostic to detect PTEN-deficient prostate tumors. PTEN is a tumor suppressor protein, and reduced activity is associated with more aggressive disease progression. Approval was supported by statistically significant improvement in radiographic progression-free survival (PFS) compared with abiraterone and prednisone alone (33.2 months vs. 25.7 months; p=0.034). Truqap is an oral selective AKT inhibitor that targets the PI3K/AKT signaling pathway, which is associated with tumor growth and survival in PTEN-deficient cancers. The recommended dose is Truqap 400mg orally twice daily, administered on an intermittent schedule of four days on treatment followed by three days off, in combination with abiraterone acetate is 1,000mg, and prednisone 5mg daily, continued until disease progression or unacceptable toxicity. Patients receiving this combination should also receive concurrent gonadotropin-releasing hormone (GnRH) analog therapy or have undergone prior bilateral orchiectomy. Here is the updated prescribing information.
Tzield Approved to Delay Beta Cell Decline in Newly Diagnosed Stage 3 Type 1 Diabetes
On June 12, 2026, the FDA granted accelerated approval to Sanofi’s Tzield® (teplizumab-mzwv), a CD3-directed monoclonal antibody, to delay the decline in endogenous insulin production in children aged eight years to 17 years who have stage three type 1 diabetes. Type 1 diabetes develops in three stages characterized by the presence of diabetes-related autoantibodies and changes in blood sugar levels, progressing from asymptomatic immune-mediated beta cell damage (Stages 1 and 2) to symptomatic disease requiring insulin therapy (Stage 3). Tzield, initially approved in 2022 to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients aged one year and older with stage 2 disease, represents the first disease-modifying therapy indicated for this population and builds on its prior use in earlier-stage disease. Approval was supported by results showing that treatment significantly slowed the decline in beta-cell function, as measured by C-peptide, compared with placebo. Tzield is administered as a series of IV infusions, with two 12-day treatment courses given at diagnosis and approximately six months later. The most common adverse events include lymphopenia, rash, leukopenia, diarrhea, and headache, while serious risks such as cytokine release syndrome and viral reactivation have been reported. Tzield’s expansion was initially reviewed through the FDA’s Commissioner’s National Priority Voucher program, but after a delayed decision process, Sanofi said the application was no longer part of the initiative, and the FDA later granted accelerated approval based on a surrogate C-peptide endpoint deemed likely to show clinical benefit. Continued approval is contingent on the confirmation of a clinical benefit in an ongoing study; results are expected in 2028. The updated prescribing information is here.
OTC Continuous Glucose Monitor Cleared for Children Two Years and Older
The FDA cleared Dexcom’s Stelo Glucose Biosensor System on June 12, 2026, as the first over-the-counter (OTC) continuous glucose monitor (CGM) for use in pediatric patients aged two years and older who do not use insulin. This approval represents an expansion of its prior clearance for adults in 2024 and is intended to provide real-time glucose monitoring without a prescription, supporting children with diabetes managed by oral medications as well as those seeking to understand how diet, exercise, and lifestyle affect glucose levels. The wearable biosensor pairs with a smartphone application to continuously measure and display glucose values and trends every 15 minutes, with each sensor lasting up to 15 days. The system is not intended for individuals requiring insulin therapy or those with problematic hypoglycemia, and users are advised to consult a healthcare provider before making medication changes.
New Hyaluronic Acid Filler Approved for Midface Contouring
On June 15, 2026, the FDA approved Waldencast’s Obagi® saypha® ChIQ™ (hyaluronic acid) injectable gel for cheek augmentation and correction of midface contour deficiencies in adult patients aged 21 years and older. Obagi Saypha ChIQ utilizes proprietary MACRO Core Technology to create a stable three-dimensional hyaluronic acid matrix designed to provide consistent particle distribution, predictable injection characteristics, and natural-looking results. This formulation builds on the prior launches in the Saypha line. The product is administered via injection by a trained healthcare professional, with published data indicating outcomes related to midface volume improvement and contour correction.
Low-Dose MRI Contrast Agent Approved for Broad Patient Use
The FDA approved Bayer’s Ambelvist® (gadoquatrane), an IV macrocyclic gadolinium-based contrast agent, for use in contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system and non–central nervous system body regions in adult and pediatric patients, including term neonates, on June 15, 2026. Ambelvist features a novel structure designed to enhance imaging signal while reducing gadolinium exposure. Use of lower-dose gadolinium-based contrast agents may help minimize cumulative exposure and tissue retention concerns, particularly in patients requiring repeated imaging. Approval was supported by data showing noninferior diagnostic efficacy compared with standard macrocyclic contrast agents at a lower gadolinium dose. The recommended dose is 0.01mmol/kg (delivering 0.04 mmol gadolinium/kg), representing approximately 60% less gadolinium than conventional agents dosed at 0.1 mmol/kg. Here is the prescribing information.
Skinvive by Juvéderm Approved for Treatment of Horizontal Neck Lines
On June 16, 2026, the FDA approved Skinvive™, a 12mg/mL hyaluronic acid gel with 0.3% lidocaine injectable for the treatment of horizontal neck lines to improve neck appearance in adults aged 21 years and older. The product is also approved to improve cheek skin smoothness in adults. The novel microdroplet formulation is injected via ultrafine needle or cannula by a trained healthcare professional. This is the first hyaluronic acid injectable specifically indicated for neck wrinkles, addressing aesthetic concerns associated with aging and “tech-neck” (caused by the head-down position used for phones, tablets, and books). Treatment effects are estimated to last around six months with optional touch-up dosing after one month. Some patients experienced temporary and generally mild-to-moderate side effects such as bruising, itching, redness, or swelling at the injection sites. More serious adverse effects, including hypersensitivity reactions and infections, are possible. Patients should not apply makeup for at least 12 hours, and they should not drink alcohol, exercise heavily, or expose newly treated skin to sunlight or high heat for at least 24 hours after treatments. Skinvive is part of the Juvéderm® line of dermal fillers, which is made by Allergan Aesthetics, one of AbbVie’s companies.
Utebzi Approved for Complicated Urinary Tract Infections
On June 17, 2026, the FDA approved Utebzi® (tebipenem pivoxil) from GSK under its licensing collaboration with Spero Therapeutics for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain susceptible pathogens in adult patients who have limited or no alternative oral treatment options. Utebzi is the first oral carbapenem antibiotic approved in the US that includes cUTIs caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis. The recommended dosage is 600mg (two 300mg tablets) taken orally every six hours for seven to 10 days in adults with appropriate renal function. Approval was supported by results from the phase III PIVOT-PO trial, which demonstrated that oral Utebzi was noninferior to intravenous imipenem-cilastatin in hospitalized adults with cUTI, including pyelonephritis. This approval provides an oral alternative to hospital-based IV carbapenems for appropriate adults. Utebzi is anticipated to launch in the US by the end of 2026; pricing has not yet been announced. For full prescribing details, see here.
FDA Approves First Generic Version of Xofluza for Influenza
On June 17, 2026, the FDA approved the first generics to Xofluza® (baloxavir marboxil – Norwich Pharmaceuticals), a single-dose oral antiviral for the treatment of acute uncomplicated influenza and post-exposure prophylaxis in patients aged five years and older. Baloxavir marboxil is a cap-dependent endonuclease inhibitor that blocks viral replication and offers a convenient alternative to multi-dose neuraminidase inhibitors. The therapy is administered as a one-time, weight-based oral dose within 48 hours of symptom onset. The approval, granted ahead of the 2026–2027 influenza season, is expected to increase access through lower-cost competition, although specific pricing has not been disclosed. It comes despite the significant burden observed during the 2025–2026 season, when the Centers for Disease Control and Prevention (CDC) estimated approximately 32 million cases, 390,000 hospitalizations, and 24,000 deaths, including 179 pediatric deaths. Norwich Pharmaceuticals is currently the first approved generic manufacturer, with additional global generic development anticipated through licensing agreements, though US launch timing beyond the initial approval has not been fully detailed. The original product, marketed by Roche/Genentech, has historically generated peak annual sales exceeding $500 million, with variability depending on flu season severity, highlighting the potential market impact of generic entry. The prescribing information will be available at Drugs@FDA.
FDA Expands Capvaxive Use to High-Risk Pediatric Patients
On June 18, 2026, the FDA approved Merck’s Capvaxive® (pneumococcal 21-valent conjugate vaccine) for the prevention of invasive pneumococcal disease in children and adolescents aged two years through 17 years who have completed a primary pediatric pneumococcal vaccination series and have chronic medical conditions that increase disease risk. Conditions that may increase a patient’s risk for pneumococcal disease include chronic heart disease, chronic lung disease, diabetes, and chronic kidney disease. Capvaxive was originally approved in June 2024 for patients at least 18 years old for the prevention of invasive disease and pneumococcal pneumonia. This expanded approval was based on the phase III STRIDE-13 trial, which demonstrated that Capvaxive was as effective as Merck’s Pneumovax 23® (pneumococcal 23-valent polysaccharide vaccine) for the 12 shared serotypes and produced statistically higher immune responses for nine serotypes unique to Capvaxive, with comparable safety and low rates of serious adverse events. The recommended regimen is a single intramuscular (IM) dose administered at least eight weeks after completion of a primary pneumococcal vaccination series. Updated prescribing information is available here.