<p>Donanemab has already received a 'breakthrough therapy' designation from the FDA</p>

<p>Several experts have said the available evidence about Aduhelm raises significant doubts about its effectiveness</p>

<p>Agency says it has granted approval on the condition that drug maker Biogen conduct a new clinical trial</p>

<p>8-mg dose of naloxone hydrochloride nasal spray now approved with 2-mg and 4-mg doses</p>