FDA Approves At-Home Initiation Option for Leqembi Iqlik in Early Alzheimer’s Disease
On July 13, 2026, the US Food and Drug Administration (FDA) approved a new indication for Eisai and Biogen’s Leqembi Iqlik® (lecanemab-irmb), the subcutaneous (SC) autoinjector, as an initiation dose for the treatment of adults who have early Alzheimer’s disease. Previously, patients were required to begin treatment with intravenous (IV) Leqembi with the option to transition to IV or SC after 18 months of therapy. The approval allows patients to receive Leqembi as either an IV infusion or SC injection throughout treatment, including at-home administration by patients or caregivers from treatment initiation through maintenance. Patients may also switch between IV and SC administration during treatment. Approval was supported by data demonstrating that once-weekly SC administration achieved drug exposure comparable to IV dosing, supporting similar amyloid plaque removal and expected clinical benefits. The approved initiation regimen is 500mg once weekly, administered as two 250mg injections delivered in approximately 15 seconds each. Leqembi Iqlik is also approved for maintenance dosing at 360mg once weekly after 18 months of treatment. The 250mg dosage strength is expected to launch in the US in late August. Here is the prescribing information.
Retevmo Converts to Traditional Approval for RET Fusion-Positive Solid Tumors
The FDA granted traditional approval to Eli Lilly’s Retevmo® (selpercatinib) on July 14, 2026. Retevmo is an oral, selective rearranged during transfection (RET) tyrosine kinase inhibitor designed to target tumors driven by RET gene fusions regardless of tumor origin, as detected by an FDA-approved test. It is indicated for adult and pediatric patients two years of age and older with locally advanced or metastatic RET fusion-positive solid tumors whose disease has progressed on or following prior systemic therapy or who have no satisfactory alternative treatment options. Previously granted accelerated approval for this tumor-agnostic indication, the action converts Retevmo to full approval based on confirmatory evidence of clinical benefit. Approval was supported primarily by results from a multicenter, open-label trial in which patients with RET fusion-positive tumors other than non-small cell lung cancer and thyroid cancer achieved an overall response rate (ORR) of 47% and a median duration of response of 24.5 months. Responses were observed across multiple tumor types, including colorectal, pancreatic, cholangiocarcinoma, salivary gland, soft tissue sarcoma, breast, ovarian, neuroendocrine and other rare cancers. The prescribing information may be found here.
Additional Generic Iohexol Presentations for Imaging Procedures Approved
On July 17, 2026, the FDA approved additional strengths of Amneal Pharmaceuticals’ iohexol injection, generics to GE HealthCare’s Omnipaque® (iohexol injection). These approvals expand Amneal’s existing iohexol portfolio, which includes the previously approved 300mg iodine/mL, which was the first generic version of Omnipaque®. The newly approved presentations include the 350mg iodine/mL in 50mL, 75mL, and 100mL vials and 300mg iodine/mL in a 50mL vial. Iohexol is indicated as a radiographic contrast agent for use in adults and pediatric patients aged two weeks and older undergoing a variety of imaging procedures, including intrathecal, intra-arterial, IV, oral, rectal, intra-articular, and body cavity imaging. According to IQVIA data, US annual sales for iohexol injection were approximately $706 million for the 12 months ending May 2026. Amneal plans to launch the newly approved presentations in Q3 2026. Here is the prescribing information.
FDA Grants Traditional Approval to Fabhalta for Slowing Kidney Function Decline in IgA Nephropathy
The FDA granted traditional approval to Novartis’ Fabhalta® (iptacopan) to slow kidney function decline in adults who have primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression on July 17, 2026. Fabhalta, an oral factor B inhibitor targeting the alternative complement pathway, was initially approved in December 2023 to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) and subsequently received accelerated approval in August 2024 to reduce proteinuria in adults with primary IgAN. The traditional approval was supported by results from the phase III APPLAUSE-IgAN study, in which Fabhalta slowed estimated glomerular filtration rate (eGFR) decline by 48% compared with placebo over two years and demonstrated clinically meaningful reductions in proteinuria as early as two weeks that were sustained throughout treatment. Fabhalta is the first complement inhibitor approved to slow kidney function decline in primary IgAN. It has a boxed warning and a risk evaluation and mitigation strategy (REMS) due to the risk of severe infections that may be associated with its use. Updated prescribing information can be found here.