Eylea Label For Retinopathy Of Prematurity Should Specify ‘Treatment Tradeoff’ Versus Laser
US FDA advisory committee recommends ‘more granularity’ in label on administration of Eylea in premature infants. Specifying intervals between injections is important for insurance coverage, agency official notes.
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Two studies failed to demonstrate that Eylea was non-inferior to laser treatment. Agency says compared to the expected natural history, there is a ‘clear beneficial effect’ of Eylea which also maintains peripheral vision. Advisory committee to discuss how to convey findings in label.
Pink Sheet reporter and editors discuss the FDA acknowledging reports of malignancies in patients who received CAR-T cell immunotherapies, the agency’s policy for using background music in direct-to-consumer advertising, and the FDA’s new incoming principal deputy commissioner.
People have challenged patent listings more than 60 times in the past six years but it is up to new drug application holders to decide whether to revise or delist their submissions.