New Bictegravir-Lenacapavir Tablet Simplifies Therapy for Hard-to-Treat HIV Patients
The US Food and Drug Administration (FDA) approved Gilead Sciences’ Bixlenvo™ (bictegravir 75mg/lenacapavir 50mg) tablets, on Aug. 27, 2026, for the treatment of HIV in virologically suppressed adults, including those maintained on complex antiretroviral regimens who cannot use currently available single tablet regimens (STRs). The regimen pairs bictegravir, a guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor that has no cross-resistance to other antiretrovirals. Bixlenvo is the first STR indicated for virologically suppressed adults on complex regimens who cannot use currently available single tablet options. Gilead estimates the population unable to use existing STRs represents about 5% of people living with HIV in the US. Approval was supported by two phase III trials, in which adults switching from complex multi-tablet regimens or from Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) maintained comparable virologic suppression at week 48, with headache, nausea, and diarrhea the most commonly reported adverse reactions and no new safety signals were identified. Patients switching to the regimen first receive a two-day oral loading dose of Sunlenca® (lenacapavir) before continuing on Bixlenvo alone. The recommended dose is one Bixlenvo 75mg/50mg tablet orally once daily, taken with an additional 600mg oral loading dose of Sunlenca (two 300mg tablets) on days one and two, followed by Bixlenvo alone once daily beginning on day three. The company expects launch within days of approval, at a list price of $4,595 for a 30-day supply. Here is the prescribing information.
FDA Approves Updated COVID-19 Vaccines for 2026-2027 Respiratory Virus Season
On Aug. 27, 2026, the FDA approved three updated COVID-19 vaccines from Moderna, Pfizer-BioNTech and Novavax-Sanofi all containing a monovalent JN.1-lineage XFG SARS-CoV-2 subvariant to help prevent COVID-19. Moderna’s updated Spikevax® (COVID-19 Vaccine, mRNA) formulation is approved for individuals aged 6 months through 64 years who have at least one underlying condition that increases the risk of severe COVID-19 and for all adults aged 65 years and older. mNEXSPIKE® (COVID-19 Vaccine, mRNA) is approved for individuals aged 12 years through 64 years at increased risk of severe disease and all adults aged 65 years and older. Pfizer and BioNTech’s Comirnaty® XFG (COVID-19 Vaccine, mRNA) is approved for adults aged 65 years and older and for individuals aged 5 years through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. Nuvaxovid™ (COVID-19 Vaccine, Adjuvanted), developed by Novavax and commercialized in the US by Sanofi, is the only protein-based, non-mRNA COVID-19 vaccine available in the US and is approved for adults aged 65 years and older and individuals aged 12 years through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The updated vaccine composition aligns with FDA recommendations for a monovalent JN.1-lineage XFG strain. Safety information remains consistent with prior COVID-19 vaccines, including risks of severe allergic reactions, myocarditis, and pericarditis for mRNA vaccines. Myocarditis and pericarditis are also risks associated with Nuvaxovid. Moderna indicated that the vaccines are expected to be available in the US within days, and Pfizer-BioNTech said that shipping began immediately. Here is the updated prescribing information for Spikevax, mNEXSPIKE and Comirnaty.
Imaavy Gets New Indication as First Treatment for Warm Autoimmune Hemolytic Anemia
On Aug. 24, 2026, the FDA approved a new indication for Johnson & Johnson’s Imaavy® (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients 12 years of age and older who are currently or previously treated with corticosteroids. This marks the first FDA-approved therapy specifically indicated for this rare, potentially life-threatening autoimmune disease in which pathogenic IgG autoantibodies attack and destroy red blood cells, causing severe anemia and debilitating fatigue. Based on an estimated prevalence of 1 in 8,000 individuals, approximately 42,000–50,000 Americans are living with wAIHA. Approval was based on a study in which approximately three times as many patients receiving Imaavy achieved a durable hemoglobin response versus placebo by week 24, along with a mean hemoglobin increase of 1g/dL as early as week one. Before this approval, wAIHA management relied on corticosteroids, immunosuppressive therapies, and off-label, B-cell-directed treatments such as rituximab. This is Imaavy’s second indication, following its April 2025 approval for generalized myasthenia gravis (gMG). The recommended dose for wAIHA is 30mg/kg administered intravenously (IV) every four weeks. The label carries warnings for increased susceptibility to infections, hypersensitivity, and infusion-related reactions, with the most common adverse reactions including peripheral edema, diarrhea, and fever. Here is the updated prescribing information.
FDA Approves Two Ziihera Combinations for HER2-Positive Gastric Cancers
On Aug. 25, 2026, the FDA approved two Ziihera® (zanidatamab-hrii)-containing regimens from Jazz Pharmaceuticals for the first-line treatment of adults who have unresectable, locally advanced or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma (GEA). The approval covers Ziihera plus Tevimbra® (tislelizumab-jsgr – BeiGene) and fluoropyrimidine- and platinum-containing chemotherapy for patients with HER2 immunohistochemistry (IHC) 3+ or IHC 2+/ISH+ tumors, regardless of PD-L1 status, as well as Ziihera plus chemotherapy alone for patients with IHC 3+ tumors. Approval was based on a study in which the triplet regimen (Ziihera plus Tevimbra and chemotherapy) reduced the risk of disease progression or death by 37% and extended median progression-free survival to 12.4 months, compared with 8.1 months for trastuzumab plus chemotherapy. The triplet also reduced the risk of death by 28%, with a median overall survival of 26.4 months versus 19.2 months for trastuzumab plus chemotherapy. This is the longest median survival reported to date in this setting, with benefits consistent regardless of PD-L1 status. Ziihera was initially approved in 2024 for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The label carries a boxed warning for diarrhea and embryo-fetal toxicity, along with additional warnings for left ventricular dysfunction and infusion-related reactions. Diarrhea was common, occurring in up to 83% of patients on the three-drug regimen, requiring preventive medication and closer monitoring. The FDA also approved two companion diagnostic devices, the PATHWAY anti-HER2/neu (4B5) antibody and the VENTANA HER2 Dual ISH DNA Probe Cocktail, to identify eligible patients. The updated prescribing information is here.
FDA Expands Tivicay PD to Newborns, Closing Gap in Neonatal HIV Therapy
The FDA approved ViiV Healthcare’s Tivicay PD (dolutegravir) tablets for oral suspension to be used in combination with other antiretroviral agents on Aug. 25, 2026, for the treatment of HIV-1 infection in newborns weighing at least 2kg from birth, extending an indication previously limited to pediatric patients aged at least 4 weeks and weighing at least 3kg. Dolutegravir is a second-generation integrase strand transfer inhibitor (INSTI) with a higher barrier to resistance, and this approval makes it the first second-generation INSTI available from birth in a population that has historically had few age-appropriate options. The dispersible tablet formulation can be dispersed in water for administration, supporting weight-based dosing in the smallest patients. Approval was supported by dolutegravir achieving target pharmacokinetic exposures in term neonates with no new safety findings compared with older pediatric populations. For the newly approved neonatal indication, Tivicay PD is administered as one tablet for oral suspension every other day. At four weeks of age, patients transition to the standard weight-based pediatric Tivicay PD dosing regimen. Tivicay and Tivicay PD are not bioequivalent and not substitutable on a milligram-per-milligram basis. Here is the prescribing information.
FDA Expands Mounjaro Label to Include Cardiovascular Risk Reduction in Type 2 Diabetes
The FDA, on Aug. 28, 2026, expanded Eli Lilly’s Mounjaro® (tirzepatide) approval to include reducing the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack or non-fatal stroke, in adults who have type 2 diabetes at high risk for these events. A dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), Mounjaro, remains approved as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes. Approval was based on SURPASS-CVOT, the first cardiovascular outcomes trial to compare two incretin therapies head-to-head rather than against placebo. Mounjaro met the primary endpoint of non-inferiority to Trulicity® (dulaglutide – Eli Lilly), a GLP-1 receptor agonist with established cardiovascular benefit. Mounjaro demonstrated an 8% lower rate of three-component MACE; however, superiority was not established. The updated prescribing information can be found here.
Recalls
Yimmugo Lots Withdrawn
Biotest AG initiated a voluntary withdrawal for certain lots of Yimmugo® (immune globulin IV, human-dira), 10% liquid, on Aug. 13, 2026. The withdrawal was initiated as a precautionary measure due to an increased rate of allergic or hypersensitivity-type reactions associated with specific lots, including a small number of medically significant reactions. Hypersensitivity and anaphylactic/anaphylactoid reactions are known risks associated with immune globulin products. Yimmugo is FDA-approved for replacement therapy in adults with primary humoral immunodeficiency (PI). For more information about this withdrawal, see here.
Thyroid Tablets Recalled
On Aug. 21, 2026, Vitruvias Therapeutics, Inc. initiated a voluntary recall for one lot of Thyroid Tablets, USP 30mg. The recall was prompted by testing that confirmed the potential for the product to be superpotent, which can cause hyperthyroidism (overactive thyroid), including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances; patients at greatest risk include the elderly, pregnant women, and infants. To date, no adverse events related to this recall have been reported. Thyroid is a natural preparation derived from desiccated porcine thyroid glands (composed of levothyroxine and liothyronine), FDA-indicated for the treatment of hypothyroidism (underactive thyroid). For more information about the recall, see here.
Sodium Chloride Injection Recalled
Baxter International Inc. announced on Aug. 25, 2026, a voluntary nationwide recall of 0.9% Sodium Chloride Injection 500mL VIAFLEX Plastic Container. The recall was prompted by the potential presence of particulate matter identified as fiberglass in the solution, which may result in serious adverse health consequences, including blood vessel blockage, pulmonary embolism, organ damage, allergic reactions, or death. The product is FDA-approved as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. For more information, see here.