Fda Approves

• The FDA has approved the first mRNA-based influenza vaccine, reversing a previous decision earlier this year to decline the application's review. • The approval covers adults aged 50 to 64, while those aged 65 and older have received accelerated approval. • This decision follows a large-scale clinical trial that yielded largely favorable results, despite an unusual initial rejection by the agency.

• The FDA has authorized Moderna’s mFlusiva, marking the first mRNA-based flu vaccine approved for use in older adults. • Separately, U.S. health officials are reviewing the nation's measles elimination status following 38 new outbreaks in 2026. • In a legal ruling, a judge designated Meta’s platforms as a "public nuisance," ordering the company to fund mental health remediation efforts.

• The FDA has approved a new engineered viral immunotherapy designed specifically for patients suffering from treatment-resistant advanced melanoma. • This approval provides a critical new therapeutic option for cancer patients who have failed to respond to existing standard-of-care treatments. • The authorization is granted under conditions where continued market availability may be contingent upon the verification of clinical benefits.

• The FDA has approved mFlusiva, marking the first time an mRNA-based vaccine has been authorized for the prevention of influenza. • Unlike traditional flu vaccines, mRNA technology allows manufacturers to produce shots more rapidly, reducing the likelihood of a mismatch between the vaccine and circulating strains. • Medical experts, including Dr. Paul Pottinger of UW Medical Center, describe the approval as a significant advancement in public health.

• The FDA has approved Replimune’s treatment for advanced melanoma, marking a significant victory for the company and patient advocates. • The drug's approval follows a tumultuous process in which it was previously rejected by the agency twice before clearing an advisory committee last week. • This decision provides a critical new therapeutic option for patients suffering from advanced stages of skin cancer.

• The FDA has approved Moderna's new mRNA-based flu vaccine, named mFlusiva, which is specifically intended for adults aged 50 and older. • This approval marks a shift toward using mRNA technology for seasonal influenza, moving away from traditional egg-based vaccine production methods. • The development is significant as it aims to provide more precise and potentially more effective protection against evolving flu strains.

• The FDA approved mFlusiva, the first mRNA-based flu vaccine developed by Moderna, on Wednesday. • The vaccine is approved for adults aged 50 to 65 and those 65 and older, with late-stage trials showing it is approximately 27% more effective than standard flu shots. • This approval is significant as it applies the same messenger RNA platform used in Pfizer and Moderna's COVID-19 vaccines to seasonal influenza.