New Moderna COVID Vaccine Formulation
On May 31, 2025, the US Food and Drug Administration (FDA) approved Moderna’s mNEXSPIKE® (COVID-19 vaccine, mRNA-1283) for use in all adults 65 years and older, and individuals between 12 years and 64 years of age with at least one or more underlying conditions that puts them at risk for severe outcomes from COVID-19. This “next generation” formulation offers lower storage temperatures and a longer shelf life than previously approved Spikevax® (COVID-19 vaccine, mRNA-1273). Phase III trials comparing the two demonstrated a higher immune response for mNEXSPIKE and fewer injection site reactions. This approval aligns with the new regulatory framework for COVID-19 vaccination approvals announced by the FDA on May 20, 2025. Launch is expected to align with the 2025-2026 respiratory virus season. Here is the prescribing information.
Nubeqa Approved for Metastatic Prostate Cancer
The FDA approved Bayer Healthcare Pharmaceutical’s Nubeqa® (darolutamide) on June 3, 2025, for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) in combination with androgen deprivation therapy (ADT). An androgen receptor inhibitor, Nubeqa was initially approved in 2019 for the treatment of non-metastatic castration-resistant prostate cancer and later approved in combination with docetaxel for mCSPC. Treatment with Nubeqa resulted in a statistically significant improvement in radiographic progression-free survival however there was no statistically significant improvement in overall survival for individuals with mCSPC. The recommended dose for Nubeqa is 600mg (two tablets) twice a day taken with food until disease progression or unacceptable toxicity. A gonadotropin-releasing hormone (GnRH) analog, such as leuprolide, also should be used for patients who have not had a bilateral orchiectomy (surgical castration). Approval was granted under Project Orbis, an FDA initiative under the Oncology Center of Excellence that speeds up approvals for drugs that may fill critical unmet needs. Updated prescribing information may be found here.
First Prolia/Xgeva Biosimilars Launch
On June 2, 2025, Sandoz announced the launch of Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the first biosimilars to Amgen’s Xgeva® (denosumab) and Prolia® (denosumab), respectively. The FDA approved these on March 5, 2024; however, Sandoz could not launch until May 31, 2025, due to a settlement agreement. Other biosimilars to Prolia and Xgeva are expected to launch this year; Wyost and Jubbonti will hold interchangeability exclusivity until Oct. 29, 2025. For prescribing information, please refer to the respective links for Jubbonti and Wyost.
Recall
Sulfamethoxazole/Trimethoprim Recalled On June 2, 2025, Amneal Pharmaceuticals recalled three lots of sulfamethoxazole/trimethoprim tablets, USP, 400mg/80mg to the consumer level. Recalled lots may have black spots that could indicate microbial contamination. Products contaminated with Aspergillus could pose a serious or life-threatening risk for patients with underlying health conditions, especially those with immunosuppression. Sulfamethoxazole/trimethoprim is an antibiotic used for treating urinary tract infections, acute otitis media, acute exacerbations of chronic bronchitis, enteritis, and other bacterial infections. For full details about the recall, see here.