Food and Drug Administration decisions and advisory committee verdicts slated for November were mostly positive. New molecular entity approvals so far this year trail 2021’s tally by about 35%.
Most FDA decisions scheduled for September yielded positive results, but there were stray disappointments as well. Seven new molecular entities, or NMEs, were approved during the month, taking the total NME approvals for the year to 24. This is far less than the 40 approvals received by the same time last year.
Regulatory decisions have yet to pick up pace this year. July’s calendar was light, but the good news was that most decisions turned out to be positive. That said, none of the drugs approved during the month were new molecular entities, underlining a lack of innovation going on in the sector.