Reuters Health News Summary

• On Thursday, August 6, 2026, the FDA granted accelerated approval to vusolimogene oderparepvec (Tudriqev), also known as RP1, for use in combination with nivolumab (Opdivo). • This genetically modified oncolytic viral therapy is specifically indicated for adults with unresectable advanced cutaneous melanoma who have seen disease progression after anti-PD-1-based therapy.

• The Department of Health and Human Services (HHS) has begun implementing President Trump’s Executive Order focused on reducing prescription drug pricing. • Robert F. Kennedy Jr. appeared before the Senate for two hearings this week as part of the confirmation process to become the next HHS Secretary.

• 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.

• The FDA has granted approval for a new narcolepsy medication developed by Takeda Pharmaceutical. • In a significant medical milestone, the first-ever mRNA-based influenza vaccine has also received FDA approval.

• 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.

• Manipal Health Enterprises' IPO saw strong oversubscription driven by institutional investors, while Glenmark Pharmaceuticals reported a 53.6% increase in quarterly profit. • An FDA advisory panel voted on Thursday to support trial results for Replimune's skin cancer drug, RP1, following a previous rejection in April due to a lack of a control group.

• 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 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.

• Moderna has launched a first-in-human Phase 1 clinical trial (NCT07737717) for mRNA-1469, an investigational vaccine targeting the Bundibugyo ebolavirus (BDBV). • The study is being conducted across three sites in Canada and aims to enroll approximately 80 healthy adult participants to evaluate safety, tolerability, and immunogenicity.

• Health Canada has authorized Moderna to begin a clinical trial for an mRNA vaccine targeting the Bundibugyo strain of the Ebola virus. • The trial aims to combat a significant and ongoing outbreak of the virus currently surging throughout the Democratic Republic of the Congo.

• Health officials have approved mFLUSIVA, the first mRNA-based flu vaccine developed by Moderna, which is expected to be available by the next flu season. • Clinical data indicates the shot may be 27% more effective than traditional vaccines, though side effects like fatigue and headaches occurred in up to two-thirds of patients.