The FDA has approved Moderna's mFLUSIVA (mRNA-1010), a seasonal influenza mRNA vaccine, for all adults aged 50 and older in the United States. mFLUSIVA becomes Moderna's fifth approved product globally and its fourth FDA approval, and the material describes it as the world's first approved influenza mRNA vaccine.
The FDA has approved Takeda's Orzeyful (oveporexton) tablets for adults with type 1 narcolepsy. It is the first drug to work by directly targeting the loss of orexin signalling that drives the disease. Orzeyful had breakthrough therapy status and was named to Drug Hunter's 2025 notable molecules list.
The US FDA has approved Novartis's Pluvicto for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), roughly doubling the eligible patient population. In the PSMAddition study, Pluvicto plus standard of care (ADT plus ARPI) reduced the risk of disease progression or death by 33% versus standard of care alone, with a positive overall survival trend (HR=0.80). About half of men with mHSPC progress within 20 months.
