Company Product Description Indication Status
Aquestive Therapeutics Inc., of Warren, N.J. Libervant (diazepam) Buccal formulation of diazepam, a benzodiazepine Seizure clusters Resubmitted a revised weight-based dosing regimen along with modeling and simulations to FDA in December 2020 and expects to receive feedback and guidance in late January
Bayer AG, of Leverkusen, Germany Nubeqa (darolutamide) Androgen receptor inhibitor  Non-metastatic castration-resistant prostate cancer FDA approved an sNDA to add overall survival and other secondary endpoint data to prescribing information, including additional guidance on drug interactions
Glaxosmithkline plc, of London, and Medicines for Malaria Venture Kozenis (tafenoquine) Antiparasitic Plasmodium vivax malaria Australian Therapeutic Goods Administration accepted submission of a category 1 application to extend indication of single-dose treatment to pediatric populations for radical cure (prevention of relapse)
Medicure Inc., of Winnipeg, Manitoba MC-1 Pyridoxal 5′-phosphate Seizures associated with pyridox(am)ine 5'-phosphate oxidase deficiency Intends to file an IND application with the FDA and will proceed with the phase III trial
Merus NV, of Utrecht, the Netherlands Zenocutuzumab Bispecific antibody targeting HER2 and HER3 receptors Neuregulin 1 fusion cancers FDA granted fast track designation
Moderna Inc., of Cambridge, Mass. COVID-19 Vaccine Moderna mRNA vaccine COVID-19 U.K.'s MHRA approved it for use under Regulation 174, a temporary authorization
Neoleukin Therapeutics Inc., of Seattle NL-201 IL-2 and IL-15 mimetic Relapsed or refractory solid tumors Received a clinical hold letter from FDA related to its IND application to begin a phase I program, stating the company needs to develop a new assay that more precisely measures the amount of protein being administered and demonstrate that dose and administration procedures will accurately deliver the intended dose 

Notes

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