Third Biosimilar to NovoLog, Garzulys, Approved
The US Food and Drug Administration (FDA) approved Garzulys™ (insulin aspart-fsan), a biosimilar to NovoLog® (insulin aspart – Novo Nordisk), on July 24, 2026, for improving glycemic control in adult and pediatric patients who have diabetes mellitus. Garzulys is a rapid-acting insulin analog approved for subcutaneous (SC) and intravenous (IV) administration and is available as a 100 units/mL (U-100) in a 3mL prefilled pen and 10mL multi-dose vial. Garzulys is the third FDA-approved biosimilar to NovoLog, following Merilog® (insulin aspart-szjj – Sanofi) and Kirsty® (insulin aspart-xjhz – Biocon Biologics), the only insulin aspart biosimilar reported to have received interchangeability designation. Launch is not yet known. Here is the prescribing information.
FDA Expands Pluvicto to Earlier-Line Metastatic Prostate Cancer
On July 31, 2026, the FDA granted an expanded indication to Novartis Pharmaceuticals Corporation’s Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adults who have prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer, [Mhspc]). This expands Pluvicto from use in metastatic castration-resistant prostate cancer to an earlier treatment setting, introducing PSMA-targeted radioligand therapy before the development of treatment resistance. Approval was based on phase III data showing that adding Pluvicto to ARPI therapy significantly reduced the risk of radiographic disease progression or death by 28% compared with ARPI therapy alone. Pluvicto is a targeted radioligand therapy that delivers beta-radiation directly to PSMA-expressing prostate cancer cells, allowing for targeted treatment while limiting exposure to surrounding tissues. The recommended dose is 7.4 GBq (200 mCi) administered IV every six weeks for up to six doses in combination with ARPI therapy. Prescribing information may be found here.
FDA Approves Additional Rituximab Biosimilar
On Aug. 3, 2026, Fresenius Kabi announced that the FDA approved Zimrixby™ (rituximab-cdxx), another biosimilar to Rituxan® (rituximab – Genentech), which was developed by Dr. Reddy’s Laboratories. Fresenius Kabi holds US commercialization rights for the product. Rituximab is a CD20-directed monoclonal antibody approved for multiple oncology and immunology indications, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. This approval adds another competitor to the rituximab biosimilar market, which includes Truxima® (rituximab-abbs – Celltrion/Teva Pharmaceutical), Ruxience® (rituximab-pvvr – Pfizer), and Riabni® (rituximab-arrx – Amgen).
Zepzelca Second-Line SCLC Indication Withdrawn Following Confirmatory Trial Failure
On Aug. 4, 2026, Jazz Pharmaceuticals announced plans, in alignment with the FDA, to voluntarily withdraw the second-line small cell lung cancer (SCLC) indication for Zepzelca® (lurbinectedin) after the phase III LAGOON trial failed to confirm clinical benefit. The study did not meet its primary endpoint of overall survival, with Zepzelca monotherapy performing worse than comparator chemotherapy regimens and the combination of Zepzelca plus irinotecan showing a numerical, but not statistically significant, survival benefit. The withdrawal follows Zepzelca’s 2020 accelerated approval for previously treated SCLC.Although the FDA previously maintained the second-line SCLC indication after the negative ATLANTIS trial due to dosing concerns and unmet clinical need, subsequent negative results from the phase III LAGOON study ultimately led to withdrawal of the accelerated approval indication.
First mRNA Flu Vaccine Approved
The FDA approved Moderna’s mFLUSIVA® (mRNA-1010) for the prevention of seasonal influenza in adults aged 50 years and older on Aug. 5, 2026, making it the first mRNA-based influenza vaccine approved in the United States. Approval for adults aged 50 to 64 years was granted through the traditional pathway, while use in adults aged 65 years and older received accelerated approval pending confirmatory postmarketing studies. mFLUSIVA uses Moderna’s messenger RNA (mRNA) platform to generate influenza antigens and stimulate an immune response. Moderna has stated that the platform may enable more rapid vaccine strain updates and greater flexibility in matching circulating influenza viruses compared with traditional influenza vaccine manufacturing methods. Approval was supported by a phase III trial of 40,805 adults aged 50 years and older across 11 countries, in which mFLUSIVA demonstrated 26.6% relative vaccine efficacy compared with a standard-dose influenza vaccine against RT-PCR-confirmed influenza-like illness. Additional data in 2,992 adults aged 65 years and older showed stronger immune responses than a high-dose influenza vaccine comparator, supporting accelerated approval, with a postmarketing trial required to confirm clinical benefit. No new or serious safety concerns were identified. Adverse reactions were consistent with those observed with other mRNA vaccines and included fatigue, joint pain, muscle aches, headache, and injection-site pain. In June 2026, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously that the benefits of mFLUSIVA outweighed the risks in adults aged 50 to 64 years and those aged 65 years and older, supporting the vaccine’s advancement toward FDA approval. Moderna expects mFLUSIVA to become available in the coming weeks ahead of the 2026-2027 influenza season. Here is the prescribing information.
Recall
Cefazolin Recalled
On July 24, 2026, Baxter International Inc. initiated a voluntary recall of cefazolin in dextrose injection, USP, 2g/100mL (20mg/mL), single-dose infusion bag, 100mL. The recall was prompted by particulate matter identified as cardboard found in the solution, which has a reasonable probability of causing pulmonary emboli and occlusion of other blood vessels, potentially leading to tissue death, organ damage or phlebitis. Additionally, infused foreign particles can trigger immune system activation, organ dysfunction and hemolysis. Cefazolin is FDA-approved for the treatment of susceptible bacterial infections and for prevention of infection before surgery. For more information, see here.