FDA Withdraws Ixchiq Vaccine Approval

On Aug. 25, 2025, the US Food and Drug Administration (FDA) suspended approval of Ixchiq^™ (live attenuated chikungunya virus vaccine – Valneva SE) for adults at an increased risk of exposure to the chikungunya virus, a mosquito-borne disease that can cause debilitating joint pain, fever and rash. The live-attenuated vaccine was initially approved in November 2023 via the accelerated approval pathway and now, reports of serious adverse events, including three deaths and 21 hospitalizations linked to chikungunya-like illness in vaccinated individuals, have raised significant safety concerns. Withdrawal follows the vaccine’s recent label updates to restrict use to those at high risk, following earlier safety concerns in older adults. The new data is not limited to older adults; therefore, the FDA determined that its benefit-risk profile no longer supports continued use, citing unresolved questions about clinical efficacy pending confirmatory trials and a growing number of serious post-marketing safety signals. Valneva must immediately cease distribution in the US, although it plans to continue supplying Ixchiq to other licensed territories. 

Repatha Gets Indication Expansion

The FDA broadened the indication for Repatha^® (evolocumab – Amgen) on Aug. 25. 2025, approving its use in adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein (LDL) cholesterol. This indication expansion removes a prior requirement to have been diagnosed with cardiovascular (CV) disease. Repatha, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, works by enhancing LDL clearance from the bloodstream. The updated label also expands monotherapy for patients with homozygous familial hypercholesterolemia (HoFH) and reinforces its role as an adjunct to diet and exercise. For treating all its indications, Repatha is injected subcutaneously (SC) once every two weeks at 140mg or once every four weeks at 420mg. Here is the updated prescribing information. 

FDA Approves Trio of Updated COVID-19 Vaccines for Fall 2025 Season

On Aug. 27, 2025, the FDA approved updated coronavirus disease 2019 (COVID-19) vaccines from Pfizer-BioNTech, Novavax and Moderna, each targeting the LP.8.1 sublineage of the JN.1 variant. Pfizer-BioNTech’s Comirnaty^® LP.8.1 (COVID-19 Vaccine, mRNA) was approved for adults 65 years and older and for individuals ages five years to 64 years of age who are at increased risk of severe illness. Novavax’s Nuvaxovid^® 2025–2026 Formula (COVID-19 vaccine, adjuvanted), a protein-based, non-mRNA vaccine, was approved for adults 65 years and older and for high-risk individuals ages 12 years to 64 years of age. Moderna received approval for two vaccines: Spikevax^® (COVID-19 Vaccine, mRNA), for people ages six months to 64 years, and mNEXSPIKE^® (COVID-19 vaccine, mRNA-1283), for those aged 12 years to 64 years of age. Both Moderna vaccines are also approved for adults 65 years and older. Alongside the approvals, the FDA revoked the Emergency Use Authorizations (EUAs) for Pfizer and Moderna COVID-19 vaccines and restricted eligibility, notably excluding pregnant women from receiving the updated vaccines. This change leaves newborns without vaccine coverage from birth to six months, as only children six months and older with high-risk conditions are eligible for Moderna’s Spikevax. In summary, all three vaccines are broadly approved for adults aged 65 and older. For individuals at higher risk, Moderna is approved starting at 6 months of age, Pfizer at 5 years, and Novavax at 12 years. Moderna’s updated vaccines are expected to be available in the coming days and Pfizer plans to begin immediate distribution to ensure broad access. The Advisory Committee on Immunization Practices (ACIP), which influences insurance coverage decisions, is scheduled to meet on September 18–19, 2025, and is expected to vote on COVID-19 vaccination recommendations that could impact access and coverage. Prescribing information can be found here for Comirnaty, Nuvaxovid, Spikevax and mNEXSPIKE.

FDA Approves New Camcevi Formulation for Advanced Prostate Cancer

On Aug. 25, 2025, the FDA approved Foresee Pharmaceuticals’ Camcevi ETM^® (leuprolide mesylate 21mg), a ready-to-use long-acting injectable (LAI) administered every three months for the treatment of advanced prostate cancer. A gonadotropin-releasing hormone (GnRH) receptor antagonist, Camcevi was initially approved in 2021 at a dose of one (42mg) SC injection once every six months administered by a healthcare professional. The recommended dose for Camcevi ETM is 21mg every three months. Other extended-release leuprolide products include Eligard^®(leuprolide acetate – Tolmar Pharmaceutical) suspension for SC injection and Lupron Depot^®(leuprolide acetate for depot suspension – AbbVie). Launch is expected after obtaining a J-code. Here is the updated prescribing information.

Recall

Octagam Recalled

On Aug. 11, 2025, Pfizer initiated a recall of Octagam^® Immune Globulin Intravenous (Human) 10% Liquid Preparation due to the potential for damaged bottles during transport. Damage to the bottles may result in leakage, reduced dosing, glass particulate contamination, and physical injury to healthcare providers, posing serious risks such as infection (including sepsis) and embolic events. Octagam is indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) and dermatomyositis (DM) in adults. For full prescribing information, see here.

Sterile Water for Injection and Sodium Chloride Irrigation Recalled

On Aug. 26, 2025, B. Braun recalled Sterile Water for Injection and Sodium Chloride 0.9% Irrigation Solution due to the chance of fluid leaking from the port site. If product leakage is not visibly apparent and the product becomes contaminated with microorganisms, there is a risk that the final mixed product may also be contaminated. This could potentially result in a bloodstream infection requiring additional medical intervention. In certain patients, such infections may pose a life-threatening risk. Sterile Water for Injection is used as a diluent in the preparation of parenteral solutions and must be mixed with appropriate solutes before intravenous administration, while Sodium Chloride 0.9% Irrigation Solution is used for general irrigation of body cavities, tissues, wounds and surgical instruments, but is not intended for injection. For more information about the recall, see here.