The US Food and Drug Administration (FDA) has approved an influenza vaccine from Moderna for older adults. The vaccine is the first licensed flu shot produced using messenger RNA technology.
In February, Vinay Prasad, who was the FDA's head of biologics at the time, issued a 'refusal to file' notice to Moderna. Prasad stated the agency would not review the vaccine based on available data. After Moderna expressed displeasure, the FDA reversed its decision and proceeded with review. Prasad left the FDA at the end of April.
The FDA has also approved a novel treatment for narcolepsy developed by Takeda. The treatment, to be marketed as Orzeyful, is a twice-a-day pill that acts as an orexin receptor agonist.
Gene-editing trial deaths in China
A six-year-old girl diagnosed with Snijders Blok-Campeau syndrome died in March 2025, one week after receiving a brain-targeted gene-editing treatment at Xinhua Hospital in Shanghai, China. The trial was conducted by neuroscientist Zilong Qiu from the Shanghai Jiao Tong University School of Medicine.
Definitely related
The family of the child in the Shanghai trial reportedly paid approximately $860,000 to finance the preclinical studies of the treatment.
A research team published a preclinical study in the journal Nature in February 2026 that did not mention the human gene-editing trial or the death in Shanghai. However, the ClinicalTrials.gov record for the Shanghai trial was updated on July 30 as 'terminated,' noting the participant died due to a serious adverse event related to the treatment.
In August 2025, a patient participating in a gene-editing trial for Duchenne muscular dystrophy died. The trial was conducted by the Shanghai-based biotechnology company HuidaGene Therapeutics.
HuidaGene Therapeutics stated that the patient developed a severe immune system reaction after receiving a high dose of the experimental treatment named HG302. The death was caused by acute respiratory distress syndrome following intense complement and cytokine activation after systemic administration of an adeno-associated virus (AAV) vector.
The period HuidaGene Therapeutics reportedly made no statement regarding the death.
Following the death in the gene-editing trial, HuidaGene Therapeutics' CEO Alvin Luk and Chief Technology Officer TJ Cradick both left their positions. The company reportedly did not make any statement regarding the death for approximately 15 months after sharing initial results at an American Gene and Cell Therapy Association conference in 2025. The death was reportedly hidden from the public for months.
