FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma - BioSpace

• 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.

• The CDC has expanded the largest known cyclosporiasis outbreak to 15 states, adding Arkansas, Iowa, Missouri, Nebraska, New Hampshire, and North Carolina to the list. • Health officials have traced the illnesses to shredded iceberg lettuce sourced from central Mexico.

• The FDA has approved the first-of-its-kind mRNA-based flu vaccine specifically for adults aged 50 and older. • This approval follows a severe 2024-25 flu season, which the CDC estimates resulted in approximately 45,000 deaths.

• Manipal Health Enterprises' $960.4 million IPO was oversubscribed, driven largely by institutional investors, while Glenmark Pharma reported a 53.6% increase in quarterly profits. • An FDA advisory panel voted on Thursday to support trial results for Replimune's skin cancer drug, RP1, following two previous FDA rejections.

• 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.