Two FDA approvals — a new drug and a new vaccine

• 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.

• 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.

• 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 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.

• Health Canada has approved a Phase I clinical trial for Moderna’s mRNA vaccine candidate targeting the Bundibugyo virus, a species of Ebola. • Canada becomes the second nation to authorize this trial, following a similar approval in the United Kingdom.

• The U.S. FDA has approved Moderna's first mRNA-based influenza vaccine specifically for adults aged 50 and older. • This decision follows a reversal of a previous refusal and leverages mRNA technology that was rapidly accelerated and proven safe during the COVID-19 pandemic.

• On July 30, 2026, Health Canada authorized Moderna to begin a Phase I clinical trial for a candidate mRNA vaccine targeting the Bundibugyo virus, a cause of Ebola disease. • The trial will evaluate whether the candidate vaccine triggers the production of antibodies in participants' immune systems to fight the virus.

• The FDA has approved mFlusiva, the first mRNA-based influenza vaccine developed by Moderna, specifically targeting adults aged 50 and older. • The regulatory strategy includes full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, pending a postmarketing study using a high-dose comparator.