Company Product Description Indication Status
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

Notes

For more information about individual companies and/or products, see Cortellis.

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