Lerochol Gains Autoinjector Formulation and Label Update
On Aug. 17, 2026, the US Food and Drug Administration (FDA) approved a new formulation of LIB Therapeutics’ Lerochol® (lerodalcibep-liga) as a 300mg/1.2mL autoinjector for use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults who have hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). The FDA also approved an updated indication statement reflecting the established reduction in major adverse cardiovascular events (MACE) associated with LDL-C lowering achieved with statins or monoclonal antibody proprotein convertase subtilisin/kexin type (PCSK) 9 inhibitors added to statin therapy. Lerochol, a PCSK9 inhibitor, offers once-monthly, self-administered subcutaneous (SC) dosing and is the first PCSK9 inhibitor approved in an autoinjector formulation with room-temperature storage for up to 90 days. Approval of the autoinjector was supported by the phase III LIBerate clinical program, in which Lerochol demonstrated sustained LDL-C reductions of approximately 60% or greater in patients with or at high risk for cardiovascular disease and approximately 59% or greater in patients with HeFH. The autoinjector delivers the same 300mg once-monthly dose currently available via prefilled syringe and is expected to become available in January 2027 at the same direct-to-patient cash price of $199 per month. Here is the prescribing information.
Stelara Biosimilar, Yesintek, Gets Prefilled Autoinjector
The FDA approved Biocon Biologics’ Yesintek® (ustekinumab-kfce) 45mg/0.5mL and 90mg/mL single-dose prefilled autoinjectors on Aug. 18, 2026. Originally approved in November 2024 in a prefilled syringe and vial presentation, Yesintek is indicated for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Launch timing and cost information were not provided. Full prescribing information is available here.
Palforzia to Be Discontinued Following Strategic Business Decision
Stallergenes Greer announced plans to discontinue Palforzia® (defatted powder of Arachis hypogaea L. [peanut]), the only FDA-approved oral immunotherapy for peanut allergy. Palforzia was approved in 2020 to mitigate allergic reactions, including anaphylaxis, from accidental peanut exposure in children with confirmed peanut allergy. The manufacturer stated this was a business decision and was not related to the product’s quality, safety, or efficacy. Reports indicate uptake of the therapy remained limited. A phased discontinuation process is underway, with product availability continuing for existing patients during the transition period until March 31, 2027.
Recall
Tyenne Recalled
On Aug. 10, 2026, Fresenius Kabi initiated a voluntary recall of Tyenne® (tocilizumab-aazg) Injection, 400mg/20mL (20mg/mL), 20mL vials. The recall was prompted by the presence of glass particles identified during an internal investigation, which may cause local irritation, pain, or swelling at the infusion site and inflammation of the veins, and more seriously may lead to vessel blockage and clotting that can cut off blood flow to vital organs, cause a life-threatening pulmonary embolism, or result in permanent organ damage or death. Tyenne is FDA-approved for the treatment of adults with moderately to severely active rheumatoid arthritis with inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs); adults with giant cell arteritis; patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis; patients 2 years and older with active systemic juvenile idiopathic arthritis; and adults and pediatric patients 2 years and older with chimeric antigen receptor (CAR) T cell–induced severe or life-threatening cytokine release syndrome and certain hospitalized adults with COVID-19. For more information about this recall, see here.
Gammaked Recalled
On Aug. 11, 2026, Grifols Therapeutics initiated a voluntary withdrawal of one lot of Gammaked™ (immune globulin injection [human], 10%), 20g. The withdrawal was conducted as a precautionary measure due to an increased rate of allergic or hypersensitivity-type reactions associated with this specific lot, a small number of which were considered medically significant. Hypersensitivity and anaphylactic or anaphylactoid reactions are a known risk with immunoglobulin products. Gammaked is FDA-approved for the treatment of primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP). For more information about the recall, see here.
Gamunex Recalled
On Aug. 12, 2026, Grifols Therapeutics initiated a voluntary withdrawal of one lot of Gamunex®-C (immune globulin injection [human], 10%), 40g/400mL vial. The withdrawal was conducted as a precautionary measure due to an increased rate of allergic or hypersensitivity-type reactions associated with these specific lots, a small number of which were considered medically significant. Hypersensitivity and anaphylactic or anaphylactoid reactions are a known risk with immune globulin products. Gamunex-C is FDA-approved for the treatment of PI, ITP and CIDP. For more information about the recall, see here.