FDA Approvals in June 2025: RSV Vaccines, Cancer Treatments, and More

June Wrap-up with Approvals

Image Credits: Biospace

Approvals

The FDA recently granted approvals for UroGen and RSV immunization. With the approval, Moderna expands mRNA RSV shot. On 13th June 2025, the FDA confirmed Moderna’s mRNA vaccine, mResvia, for respiratory syncytial virus, a solution of inoculation for adults aged 18 to 59 years. Meanwhile, the CDC suggested the broad use of RSV shots that offer blanket vaccination for individuals 75 years and older. The CDC provides immunization to the higher-risk of extreme RSV patients, ranging from 60 to 74 years.

Further, Merck’s RSV antibody received approval from the FDA and has appeared as a new challenge/competition for AstraZeneca and Sanofi. Merck’s anti-RSV antibody clesrovimab for infants is a marketed therapy in the brand name ‘Enflonsia’. AbbVie’s Mavyret, an oral antiviral, received approval because of phase 3 single-arm prospective trial data involving the treatment of 300 patients with acute infected treatment.

Additionally, the FDA granted the use of Bayer’s oral androgen receptor blocker Nubeqa for patients suffering from metastatic castration-sensitive prostate cancer (McSPC) despite concurrent chemotherapy. Urogen received clearance from the FDA for the intravesical drug mitomycin for low-grade intermediate-risk non-muscle invasive bladder cancer treatment. Urogen will be marketed as a brand name ‘Zusduri’. Datroway, an antibody drug commercialized by Daiichi Sankyo and AstraZeneca, received approval.

Another, Nuvation Bio’s oral ROS1 blocker taletrectinib, under the brand name Ibtrozi, received approval from the FDA on 12th June 2025. It’s the first commercial product. Ibtrozi’s received clearance because of its phase 2 trust-1 and trust-2 trials data, which is a combined account for a known clinical trial program in ROS1+NSCLC. BeOne, also known as BeiGene also received approval for a new medicine (tablet) of the tyrosine kinase inhibitor brukinsa (twice a day). This will directly source approval for other indications of Brukinsa, like marginal zone lymphoma, Waldenstrom’s macroglobulinemia, small lymphocytic lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia.

Change

The approvals of the drugs and therapies mentioned above have contributed to the healthcare market. The highest investment, acquisitions, and collaboration have fueled clinical trials and smooth the study covering a broader concept of new medicines and innovation in treatment, and more. The advancement and opportunities in the healthcare sector have helped to identify the severe areas and unmet needs of patients. Science has reached a healing and prospering stage with the support of the government initiative and global healthcare industries/leaders, and providers. Every approval comes with a solution, requiring efforts from experts and healthcare professionals to accept and use it appropriately.