The latest global regulatory news, changes and updates affecting biopharma, including: NIH lays out final policy on data sharing; NICE to review Spinraza data; Olinvyk a Schedule II; FDA issues REMS MAPP.
Knocked back by a complete response letter (CRL) in late 2018, Trevena Inc. dusted itself off, resubmitted its NDA for oliceridine and found satisfaction as the FDA has approved the opioid agonist.