FDA started 2012 with a bang: five novel approvals in January, including two of the fastest approval times in modern agency history (and the fastest therapeutic approval outside of oncology), plus two big decisions on anti-diabetics.
CDER was fast off the starting blocks in 2012, approving five novel agents in January – including a one-two punch of two with the shortest approval times in recent agency history on the last two days of the month.
The January 2012 novel approvals are dominated by oncology products (4 of 5), priority reviews (3 of 5) and small...
Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
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.
