RE:RE:RE:NR : FDA accepts LMNL's BLA (Riplazym)From FDA approval list . I found it 2 years ago when the BLA was rejected for CMC issue. So I search on the FDA site for information about other pharma who had their BLA/NDA rejected for CMC reasons in order to know more about that kind of rejections.
Their was a list of BLA/NDA approbation after a resubmission with all the details (pharma names, drug names, cmc issues and time between resubmission and approval.
I will try to find it again and post it