|Kempharm Inc., of Celebration, Fla.||KP-415||Serdexmethylphenidate, a prodrug of d-methylphenidate||Attention deficit hyperactivity disorder||Received a Day-74 letter from the FDA stating that the NDA is sufficiently complete to permit a substantive review by the FDA; the target PDUFA date is March 2, 2021|
|Novartis AG, of Basel, Switzerland, and its Avexis unit||Zolgensma (onasemnogene abeparvovec)||Gene therapy expressing SMN||Spinal muscular atrophy||European Commission granted conditional approval for babies and young children with SMA up to 21 kg|
|Organicell Regenerative Medicine Inc., of Miami||Organicell Flow||Acellular product derived from amniotic fluid||COVID-19||FDA authorized 2 emergency compassionate use INDs; the severely ill patients received immediate administration of Organicell Flow|
|Theralase Technologies Inc., of Toronto||TLD-1433||Light-activated photodynamic compound||Non-muscle invasive bladder cancer||FDA granted IND authorization to conduct a phase II study in the U.S.|
|Tolero Pharmaceuticals Inc., of Salt Lake City||TP-1454||Small-molecule PKM2 activator||Advanced metastatic or progressive solid tumors||Submitted an IND application to the FDA|
For more information about individual companies and/or products, see Cortellis.