FDA Approves First Iron-Based MRI Contrast Agent for Brain Imaging
On Oct. 17, 2025, the US Food and Drug Administration (FDA) approved Azurity Pharmaceuticals’ Ferabright™ (ferumoxytol injection), the first iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain. Ferabright is indicated for use in adults with known or suspected brain neoplasms to visualize lesions with a disrupted blood-brain barrier. In clinical trials, Ferabright-enhanced MRI improved the detection of brain tumors compared with non-contrast MRI. The agent’s extended half-life reduces the need for repeat dosing. Unlike gadolinium-based agents, Ferabright is processed through natural iron pathways and is considered safe for patients who have kidney impairment, minimizing concerns about heavy metal exposure and long-term retention. The recommended dose is based on body weight with those weighing 50kg or less using 300mg elemental iron per 10mL (30 mg/mL) and those weighing 51kg or more using 510mg elemental iron per 17mL (30 mg/mL) for intravenous (IV) infusion over at least 15 minutes. Ferabright is contraindicated in individuals with known hypersensitivity to ferumoxytol, any component of the formulation or other IV iron products. Reported reactions have included serious hypersensitivity events such as anaphylaxis. View the full prescribing information here.
Tezspire Gains FDA Approval for Chronic Rhinosinusitis with Nasal Polyps
The FDA approved Tezspire® (tezepelumab-ekko – Amgen/AstraZeneca) on Oct. 17, 2025, as an add-on maintenance treatment for adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Initially approved in 2021 for severe asthma, Tezspire is a fully human monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), making it the first biologic approved for CRSwNP to target this upstream inflammatory pathway. Approval was based on phase III WAYPOINT trial data showing significant reductions in nasal polyp size and congestion at week 52, with a 98% reduction in the need for surgery and an 88% reduction in systemic corticosteroid use. Improvements in sense of smell and quality-of-life scores were also observed. The recommended dose is 210mg administered subcutaneously (SC) once every four weeks. Tezspire is available as a single-dose vial, prefilled syringe or prefilled pen; the pen may be used by patients or caregivers after proper training. Common adverse reactions include nasopharyngitis, upper respiratory tract infection, epistaxis and injection site reactions. See full prescribing information here.
New Lupus Nephritis Indication for Gazyva
The FDA approved Genentech’s Gazyva® (obinutuzumab) on Oct. 20, 2025, for an additional indication for the treatment of adult patients who have active lupus nephritis (LN) receiving standard therapy. A serious complication of systemic lupus erythematosus (SLE), LN impacts about 1.7 million Americans and leads to progressive kidney damage marked by irreversible loss of filtering structures and frequent disease flares. Despite available treatments, up to one-third of patients may advance to end-stage kidney disease, with dialysis or transplant as the only remaining options. Gazyva is a CD20-directed monoclonal antibody, previously approved for oncology indications only, and has now expanded into autoimmune diseases. Approval for LN was based on trial results showing 46.4% of patients receiving Gazyva plus standard therapy achieved complete renal response (CRR) compared to 33.1% in patients treated with standard therapy alone. Additional benefits included improved complement levels, reduced anti-dsDNA antibodies, lower corticosteroid use and decreased proteinuria. Gazyva is administered IV with a shortened 90-minute infusion time after the initial dose for eligible patients. The recommended regimen includes 1,000mg infusions at week zero, two, 24, and 26, followed by twice-yearly maintenance dosing. The updated prescribing information can be found here.
FDA Approves the First Incision-Free Corneal Cross-Linking Therapy for Keratoconus, Epioxa
On Oct. 20, 2025, the FDA approved Glaukos Corporation’s Epioxa™ HD (riboflavin 5’-phosphate ophthalmic solution) 0.239% and Epioxa™ (riboflavin 5’-phosphate ophthalmic solution) 0.177%, both photo enhancers indicated for use in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O2n™ System and the Boost Goggles®. Keratoconus is a progressive eye disease causing thinning and weakening of the cornea that can lead to severe vision loss or blindness if untreated; while conventional treatments address symptoms, they do not halt disease progression, and up to 20% of patients may ultimately require a corneal transplant. Standard care includes eyeglasses, rigid contact lenses and corneal cross-linking. Epioxa is the first FDA-approved incision-free corneal cross-linking therapy that preserves the corneal epithelium, the eye’s outer protective layer. Glaukos’ Photrexa® (riboflavin 5′-phosphate ophthalmic solution) 0.146% and Photrexa® Viscous (riboflavin 5′-phosphate in 20% dextran ophthalmic solution) 0.146% were approved in 2016 as the first FDA-approved corneal cross-linking therapy for keratoconus, requiring removal of the corneal epithelium, which is a painful procedure with extended recovery time. Epioxa offers a non-invasive, incision-free alternative that preserves the epithelium. Approval was supported by two phase III pivotal trials, which demonstrated statistically significant improvements in corneal stability and safety. The therapy is administered in a single session using a proprietary ultraviolet activation system. Commercial launch is expected in early 2026. Here is the prescribing information.
Generic to Ravicti Oral Liquid Launched
Endo USA, a subsidiary of Mallinckrodt and Par Pharma, announced the FDA approval and launch of the first generic equivalent of Amgen’s Ravicti® (glycerol phenylbutyrate) 1.1g/mL oral liquid on Oct. 20, 2025. Glycerol phenylbutyrate oral liquid is approved for the chronic management of urea cycle disorders in adults and children who are not adequately controlled by dietary protein restriction alone; it must be used in combination with a low-protein diet and, when necessary, nutritional supplements. Due to a settlement agreement, other glycerol phenylbutyrate generics are expected to launch in six months. Annual US Sales for Ravicti were $528 million in 2024.
FDA Approves Oral Semaglutide for Cardiovascular Risk Reduction in Type 2 Diabetes
On Oct. 17, 2025, the FDA approved Novo Nordisk’s Rybelsus® (oral semaglutide) 7mg and 14mg to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular (CV) death, nonfatal myocardial infarction and nonfatal stroke in adults with type 2 diabetes who are at high CV risk, regardless of prior CV events. This marks the first oral glucagon-like peptide-1 (GLP-1) receptor agonist with a CV risk reduction indication. Approval was based on a study that found a 14% relative risk reduction in MACE over a median follow-up of about four years compared with placebo, driven primarily by fewer nonfatal myocardial infarctions. The safety profile was consistent with prior studies, though gastrointestinal events were more common and led to higher discontinuation rates (15.5% vs 11.6% for placebo). The recommended dose is 14mg once daily, taken on an empty stomach with water at least 30 minutes before food or other medications. Novo Nordisk’s Ozempic® (semaglutide) and Wegovy® (semaglutide) are approved for MACE, however only with known CV disease. Eli Lilly plans to submit Mounjaro® (tirzepatide) for a MACE indication by the end of 2025 with Zepbound® (tirzepatide) expected later as it is currently in phase III studies. Additionally, Novo Nordisk is pursuing a once-daily oral formulation of semaglutide under the Wegovy® brand for obesity, with a decision expected later in 2025. Here is the updated Rybelsus prescribing information
Yuflyma, Humira Biosimilar, Approval Expanded to Pediatric HS and UV Patients
On Oct. 17, 2025, the FDA approved expanded indications for Yuflyma® (adalimumab-aaty – Celltrion) and its unbranded version to include treatment of hidradenitis suppurativa (HS) in adolescents aged 12 years and older and uveitis (UV) in pediatric patients aged two years and older. Yuflyma, a high-concentration, citrate-free, interchangeable biosimilar to Humira® (adalimumab – AbbVie), was initially approved in 2023 for a variety of inflammatory conditions, including HS and UV in adults. This is the first Humira biosimilar to hold pediatric indications for HS and UV. It is available in prefilled syringes (20mg, 40mg, 80mg) and autoinjectors (40mg, 80mg). For adolescent HS, patients weighing 30kg to less than 60kg receive 80mg on day one, followed by 40mg on day eight and every other week thereafter. If the patient weighs 60kg or greater, the recommendation is to follow adult dosing of 160mg on day one as a single dose or split over two days followed by 80mg on day 15, then 40mg weekly or 80mg every other week starting day 29. For pediatric UV, dosing aligns with juvenile idiopathic arthritis: 20mg every other week for patients weighing 15kg to less than 30kg, and 40mg every other week for those 30kg and above. The updated prescribing information is here.
FDA Approves Blenrep for Third-Line Multiple Myeloma After Market Withdrawal After being removed from the market in 2022, on Oct. 23, 2025, the FDA approved GSK’s Blenrep® (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. A B-cell maturation antigen (BCMA)-directed antibody-drug conjugate, it initially received accelerated approval as monotherapy for relapsed or refractory multiple myeloma after four or more previous treatments. After the results of an FDA-required clinical trial failed to show any significant advantage for Blenrep, GSK withdrew it from the US market. This new approval is based on the phase III DREAMM-7 trial, which demonstrated that Blenrep in combination with bortezomib and dexamethasone significantly improved progression-free survival compared to the standard regimen of daratumumab, bortezomib and dexamethasone. The Blenrep regimen reduced the risk of death by 51% and tripled median progression-free survival to 31.3 months, compared with 10.4 months for a daratumumab-based triplet. Despite its efficacy, the prescribing information includes a Boxed Warning citing ocular toxicity, including corneal changes that may impair vision. In the DREAMM-7 trial, 92% of patients experienced eye-related side effects, with 77% reporting severe cases and 83% requiring dose adjustments. Due to these risks, the drug is available only through the Blenrep Risk Evaluation and Mitigation Strategy (REMS) program. Additional warnings include potential for thrombocytopenia and embryo-fetal harm. Notably, the FDA did not approve Blenrep in combination with Pomalyst® (pomalidomide – Bristol Myers Squibb) and dexamethasone, citing safety concerns and limited US patient representation in clinical trials. Although the FDA did grant the Blenrep, bortezomib and dexamethasone approval, it is narrower than GSK had requested and follows a July vote by the FDA’s Oncologic Drugs Advisory Committee, which opposed both proposed combinations due to high rates of ocular toxicity and the need for optimized dosing. The recommended dose is 2.5mg/kg every three weeks, initially in combination with bortezomib and dexamethasone for eight cycles, followed by monotherapy until disease progression or unacceptable toxicity. The new approval marks its return to the US market and GSK is planning to relaunch Blenrep in early 2026. The prescribing information will be available in the Drugs@FDA drug database.