Approval of Leqembi comes after controversial approval in 2021 of Aduhelm, which met with criticism over concerns about that drug's effectiveness, safety, pricing
Extrapolation of the findings from pivotal clinical trials to the approved indication most common for disease severity
Request follows reports that Biogen and the FDA held off-the-books meetings before the drug's approval that may have violated FDA protocol
FDA approved Aduhelm earlier this month, despite advisory committee's conclusion that there was not enough evidence to support its effectiveness
Several experts have said the available evidence about Aduhelm raises significant doubts about its effectiveness
Agency says it has granted approval on the condition that drug maker Biogen conduct a new clinical trial
8-mg dose of naloxone hydrochloride nasal spray now approved with 2-mg and 4-mg doses