Sponsors seek clarity about the transition process, which could last a year or longer.
As calls increase to move beyond the coronavirus pandemic and return to normal life, sponsors are growing uneasy about the future of the drugs available under emergency use authorizations.
EUAs are intended to allow temporary use of a product during a public health emergency, but cannot remain available once...
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
