Productivity remains high as full ANDA approvals reached a FY 2020 peak and complete responses dropped to another low in June.
Generic drug sponsors notched a double win with the US Food and Drug Administration in June: increased application clearances and reduced complete responses.
The FDA’s generic drugs program continued its productivity boost since the coronavirus pandemic began, posting a fiscal year 2020 high...
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.
