Health Care

FDA head acknowledges possible missteps in Aduhelm approval – STAT

Top of the morning to you and a fine one, it is. Moderate temperatures and clear skies are enveloping the Pharmalot campus this morning, a pleasant respite from the mugginess of the past couple of days. Nonetheless, nothing will stop us from reaching for a steaming cup of stimulation. Our choice today is cinnamon hazelnut, for those tracking this sort of thing. After all, the neurons need a little help. And since no prescription is required, so much the better. Now, though, on to another busy day with a few tidbits to devour. Enjoy, and good luck. …

Acting Food and Drug Administration Commissioner Janet Woodcock acknowledged her agency may have misstepped in its handling of its polarizing approval of a new Alzheimer’s drug from Biogen (BIIB), STAT tells us. She was emphatic in defending the therapy and the agency approval, but said “it’s possible that the process could have been handled in a way that would have decreased the amount of controversy involved. Was the process done exactly the best that it could be? Possibly not.”

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