Hympavzi’s Hemophilia Approval Expanded to Include Pediatrics and Disease with Inhibitors
On June 8, 2026, the US Food and Drug Administration (FDA) approved Pfizer’s Hympavzi® (marstacimab-hncq) for expanded use as a once-weekly subcutaneous (SC) prophylactic treatment to prevent or reduce bleeding episodes in adults and pediatric patients aged six years and older with hemophilia A or B, including individuals with or without inhibitors. Initially approved for those 12 years and older without inhibitors, Hympavzi is an anti–tissue factor pathway inhibitor (TFPI) monoclonal antibody delivered via a prefilled pen or syringe, now available down to six years of age and those 12 years and older who have developed inhibitors. Approval for 12 years and older with inhibitors was supported by a statistically significant 93% reduction in treated annualized bleeding rate (ABR) with once-weekly Hympavzi compared with on-demand intravenous (IV) bypassing therapy (1.4 vs 19.8; p<0.0001). For pediatric patients six years and older, approval was supported by interim data showing a lower mean ABR with Hympavzi than the higher historical rates observed with routine prophylaxis or on-demand treatment. Hympavzi is administered as a once-weekly SC regimen with an initial loading dose followed by maintenance dosing, with higher doses used in adults and adolescents and lower weight-based dosing used in pediatric patients ages six years to less than 12 years. Dose escalation may be considered in both groups to optimize bleed prevention, with flexibility to adjust weekly dosing based on clinical response. Full prescribing information may be found here.
FDA Expands Sunscreen Options with First New Active Ingredient in Decades
On June 9, 2026, the FDA announced the addition of bemotrizinol to the list of over-the-counter (OTC) permitted sunscreen ingredients for broad-spectrum sun protection in adults and children aged six months and older. While several additional UV filters, including bemotrizinol, have been widely used in Europe and other international markets for years, this marks the first addition of a new sunscreen active ingredient in the United States since the late 1990s and is intended to support innovation and expand consumer choice. Bemotrizinol is a chemical ultraviolet (UV) filter that provides protection against both UVA and UVB rays and demonstrates low systemic absorption through the skin with minimal irritation risk, supporting its classification as generally recognized as safe and effective (GRASE). Sunscreen products containing bemotrizinol may enter the market without a traditional drug application if they meet OTC monograph requirements for use, concentration, and labeling. Existing OTC sunscreen products in the US rely on a limited set of previously approved chemical filters (avobenzone) and mineral agents (zinc oxide and titanium dioxide), which must be combined to achieve broad-spectrum UVA and UVB protection. This action was initiated by an OTC Monograph Order Request submitted by DSM Nutritional Products to add bemotrizinol, at concentrations up to 6%, as a new active ingredient in the OTC sunscreen monograph.
Extended Dosing Approved for Ebglyss in Atopic Dermatitis
The FDA approved Eli Lilly’s Ebglyss® (lebrikizumab-lbkz) for an extended maintenance dosing regimen of once every eight weeks for the treatment of moderate-to-severe atopic dermatitis on June 9, 2026. It is approved in adults and pediatric patients aged 12 years and older weighing at least 40kg (88 pounds) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. This approval expands on prior labeling that included every-four-week maintenance dosing. Ebglyss is an interleukin-13 (IL-13) inhibitor that targets key inflammatory pathways associated with atopic dermatitis and may be used with or without topical corticosteroids. Approval was based on comparable disease control with every-eight-week dosing versus more frequent regimens over 32 weeks, with no new safety signals observed and no discontinuations due to adverse events. The recommended dose includes an initial loading regimen of 500mg (two 250 mg SC injections) administered at weeks zero and two, followed by 250mg every two weeks until at least week 16 or until an adequate clinical response is achieved, after which maintenance dosing is administered SC every four weeks, with the option to extend to every eight weeks. Here is the updated prescribing information.
FDA Expands Indications for Actemra Biosimilar Tofidence
On June 10, 2026, the FDA approved Organon’s Tofidence® (tocilizumab-bavi), a biosimilar to Actemra® (tocilizumab – Genentech), for expanded use in adults and pediatric patients aged two years and older for the treatment of chimeric antigen receptor (CAR) T cell–induced severe or life-threatening cytokine release syndrome (CRS) and for hospitalized COVID-19 patients requiring systemic corticosteroids and respiratory support. This approval expands on prior indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis (sJIA); however, systemic sclerosis–associated interstitial lung disease (SSc‑ILD) remains an Actemra-only indication. The monoclonal antibody biosimilar targets interleukin-6 (IL-6) mediated inflammation and is administered via intravenous (IV) infusion. Tofidence was first approved in 2023 as the first US biosimilar to Actemra and launched in May 2024. The updated prescribing information can be found here.
Generic Astagraf XL Launches
Tacrolimus extended-release (ER) capsules, the generic equivalent to Astagraf® XL (tacrolimus ER – Astellas Pharma), are now available, with Amneal Pharmaceuticals among the initial launch manufacturers. The calcineurin inhibitor is indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving a kidney transplant, in combination with other immunosuppressants as a once-daily extended-release formulation of tacrolimus for transplant maintenance therapy. Annual US sales for 2025 were $12 million.
Generics to Xeljanz XR Now Available
In early June 2026, the first A‑rated generics to Pfizer’s Xeljanz XR® (tofacitinib extended‑release) tablets, 11mg and 22mg, became available. Tofacitinib is a Janus kinase (JAK) inhibitor indicated for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers. Multiple manufacturers, including Apotex, Aurobindo, Dexcel, and Zydus, have already launched generics to the higher‑volume 11mg tablets; however, Zydus is currently the only supplier of the 22mg strength with 180‑day exclusivity. US sales for the Xeljanz franchise were approximately $3.4 billion in 2025.
Generic Opsumit Launched
The first A-rated generics to United Therapeutics’ Opsumit® (macitentan) became available on or around June 5, 2026. The drug is an endothelin receptor antagonist (ERA) approved to treat pulmonary arterial hypertension (PAH) in adults to reduce the risks of disease progression and hospitalization for PAH. Currently, Aurobindo, Season Biotechnology, and Sun have launched generics to 10mg tablets; however, additional manufacturers are expected to launch in 2026. Opsumit had annual US sales of approximately $1.7 billion in 2025.
MedWatch Update
FDA Adds Kidney Risk Warning to Weight-Loss Drug Orlistat
The FDA approved labeling changes for orlistat products on June 10, 2026, including both OTC alli® (orlistat – Haleon/generics) 60mg oral capsules and prescription Xenical® (orlistat – Chepla Pharma) 120mg capsules, adding a warning about rare but serious risks of acute kidney injury and kidney stones. Alli is an OTC lipase inhibitor indicated for weight loss in overweight adults when used with a reduced-calorie, low-fat diet, while Xenical requires a prescription and is indicated for obesity management, including weight loss and maintenance, and reduction of weight regain risk. FDA postmarketing review identified 12 reported cases from safety databases and the literature of kidney-related adverse events associated with orlistat, including acute kidney injury, oxalate nephropathy, and kidney stones. These findings, along with biologic plausibility and evidence that risk may occur at both prescription (120 mg) and OTC (60 mg) doses, supported adding a kidney injury warning across all orlistat product labeling. Patients with a history of kidney disease are now advised to consult a health care provider prior to use, and patients should discontinue therapy and seek medical attention if symptoms such as back or groin pain, hematuria, decreased urination, or extremity swelling occur. The recommended OTC dosing remains one 60mg capsule with each fat-containing meal, up to three times daily.
Recall
Haleon Issues Voluntary Recall of Gas-X Extra Strength Due to Potential Contamination
On June 4, 2026, Haleon announced a voluntary recall of its Gas‑X Extra Strength Softgels (simethicone) 125mg due to potential chemical contamination during packaging affecting select lots. The recall was initiated following the identification of a machine leak that may have introduced a diluted propylene glycol–based coolant into some capsules. If ingested, it could result in gastrointestinal adverse events such as nausea, vomiting, abdominal pain, and diarrhea. No adverse events have been reported to date. The OTC product is indicated to relieve gas-related symptoms, including bloating, pressure, and abdominal discomfort, by breaking up gas bubbles in the digestive tract. Patients are advised to stop use and contact the manufacturer for return and reimbursement. The FDA recall notice is available here.
Infectious Disease Outbreaks: 2026 Hantavirus and Ebola Issues Document Now Available
In May 2026, two distinct infectious disease outbreak situations have drawn public health attention: a multi-country hantavirus cluster linked to a cruise ship outbreak of Andes virus and an Ebola outbreak caused by Bundibugyo virus in the Democratic Republic of the Congo (DRC) with cross-border cases in Uganda. The hantavirus event remains a low-risk event for broad community spread, while the Ebola outbreak has prompted a Public Health Emergency of International Concern (PHEIC) because of international spread risk, uncertainty about the scale of transmission, and the absence of approved strain-specific vaccines or therapies for the Bundibugyo virus. This document summarizes these evolving infectious disease events to support informed, evidence-based education on the subject.