BESREMi Expands into Essential Thrombocythemia
ET is a rare chronic myeloproliferative neoplasm characterized by excessive platelet production, and this approval marks the first new approved treatment for this disease in nearly three decades. BESREMi is a long-acting, monopegylated interferon designed to target disease-driving cells in the bone marrow while reducing elevated platelet counts and overall disease burden. The approval applies regardless of genotype or disease status, including newly diagnosed patients who are naïve to cytoreductive therapy. Approval was based on results from the phase III SURPASS-ET trial, in which BESREMi achieved a higher durable Modified European LeukemiaNet (ELN) response rate than anagrelide at months nine and 12 (37.4% vs. 3.6%), including remission of blood counts, improvement or non-progression of splenomegaly, and absence of bleeding or thrombotic events. The approval expands BESREMi’s potential reach to an estimated 148,000 patients with ET in the US. BESREMi is administered by subcutaneous (SC) injection starting at 250mcg, increasing to 350mcg after two weeks and 500mcg after four weeks, followed by maintenance dosing every two weeks. Here is the updated prescribing information.
Stelara Approved for Pediatric Ulcerative Colitis
The FDA expanded Johnson & Johnson Innovative Medicine’s Stelara® (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients aged two years and older on Aug. 28, 2026. This follows the drug’s April 2026 approval for pediatric Crohn’s disease, making Stelara the first approved monoclonal antibody that does not target tumor necrosis factor alpha (TNF-α) for both major forms of pediatric inflammatory bowel disease (IBD).Stelara is an interleukin (IL)-12/23 inhibitor that targets inflammatory pathways involved in the development of ulcerative colitis and other immune-mediated diseases. The approval was supported by evidence from adult UC studies, pharmacokinetic and safety data from pediatric Crohn’s disease patients aged two to 17 years and a 52-week study involving 112 pediatric patients with UC aged three to 17 years. In the study, 40.5% of induction responders achieved clinical remission at week 52, while 65.8% achieved symptomatic remission and 40.5% achieved endoscopic improvement. Stelara is administered as a single weight-based intravenous (IV) induction dose followed by SC maintenance injections every eight weeks. The updated prescribing information can be found here.
FDA Adds Boxed Warning to Injectafer for Hypophosphatemia
On Sept. 1, 2026, the FDA added a boxed warning, the agency’s most prominent safety warning, to the labeling for American Regent’s Injectafer® (ferric carboxymaltose injection, 50 mg/mL), describing the risk of severe, prolonged symptomatic hypophosphatemia. Injectafer is an IV iron replacement therapy initially approved in 2013 to treat iron deficiency anemia. The boxed warning notes that hypophosphatemia has occurred in patients with normal baseline phosphate levels and without apparent risk factors, and can lead to hospitalization, osteomalacia and fractures requiring clinical intervention. The label change followed a 2026 FDA assessment of the FDA Adverse Event Reporting System (FAERS), published literature and the Sentinel System, which identified 134 reports and published cases of serious symptomatic hypophosphatemia between July 2022 and June 2025 and found phosphate testing rates remain low despite prior label revisions in February 2020 and May 2023. Cases occurred after both single and multiple infusions and often required hospitalization, phosphate replacement over weeks to months and extended monitoring. Clinicians should correct pre-existing hypophosphatemia before administration, check serum phosphate before a repeat course in patients at risk and in any patient re-treated within three months, treat hypophosphatemia as medically indicated, and consider permanent discontinuation for severe or persistent cases. Patients should be counseled to report muscle weakness or pain, fatigue, bone and joint pain, tremors, confusion, seizures and cardiac arrhythmia. Indications and dosing are unchanged. Here is the updated prescribing information.
Recalls
Sodium Chloride Injection Recalled
B. Braun Medical Inc. announced on Aug. 19, 2026, a voluntary nationwide recall of three lots of 0.9% Sodium Chloride Injection USP, 100mL, in a 150mL PAB® Container. The recall was prompted by the presence of particulate matter identified as zinc oxide in the solution. Intravenous administration of particulate matter may result in serious adverse health consequences, including pulmonary emboli, blood vessel occlusions that can lead to tissue death and organ damage, phlebitis, immune system activation, organ dysfunction and hemolysis. To date, no serious injuries, deaths or other adverse events related to this issue have been reported. The product is FDA-approved for use in adults and pediatric patients as a source of electrolytes and water for hydration and as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. For more information about the recall, see here.
Exenatide Recalled
On Aug. 31, 2026, Amneal Pharmaceuticals LLC initiated a voluntary recall of exenatide injection, 250 mcg/mL, due to the potential for some autoinjector pens to be distributed without medication. Exenatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Use of an affected device may fail to deliver the intended dose, leading to reduced glucose-lowering effects and potentially inadequate blood sugar control. For more information about the recall, see here.
Product Correction for Actidose Products
On Sept. 1, 2026, Padagis US LLC issued a product correction for all lots of Actidose with Sorbitol, Actidose Aqua 50g and Actidose Aqua 15g due to clarification of patient dosing directions to ensure conformity with OTC Activated Charcoal Monograph M023 requirements. The action was initiated to update product labeling and directions for use. No product quality, sterility, potency, contamination or manufacturing concerns were identified in the notice. Patients or providers with questions should contact Padagis directly for additional information by calling 866.634.9120 or email Consumer.Support@Padagis.com.