Tag

Fda Advisory Committee

All articles tagged with #fda advisory committee

healthcare26 days ago•6 min saved

Advisory panel backs Replimune’s RP1 for melanoma despite data questions

An FDA advisory committee voted 10-3 in favor of Replimune’s RP1 oncolytic virus (with Opdivo) for advanced melanoma, citing signs of efficacy despite significant trial-design concerns that the FDA flagged (no control arm, RECIST deviations, reinjection artifacts). While some data hint at systemic activity, the panel stressed uncertainty and noted the ongoing Ignyte-3 phase 3 data as pivotal; the FDA decision on RP1 is expected by August 2 amid a large unmet need for refractory melanoma treatments.

via Fierce Biotech|

#fda-advisory-committee #healthcare #ignyte

health2 months ago•4 min saved

FDA panel backs first mRNA flu shot for older adults

An FDA advisory panel unanimously recommended approving Moderna’s mFlusiva, the first influenza vaccine made with mRNA technology, for adults ages 50–64 and 65+ pending final FDA clearance by early August. The shot could enable faster manufacturing and better matching to circulating strains. In trials, it reduced flu cases by about 27% in people 50+ versus a standard vaccine and produced a strong immune response in 65+ compared with a high-dose vaccine, with mostly mild, temporary reactions. If approved, Moderna will run a large follow-up study (about 400,000 people 65+) over two seasons to gather more safety and efficacy data, including in frail or immunocompromised individuals.

via ScienceAlert|

#fda-advisory-committee #health #influenza