Company Product Description Indication Status
Kronos Bio Inc., of San Mateo, Calif. Entospletinib  Spleen tyrosine kinase inhibitor Newly diagnosed with NPM1-mutated acute myeloid leukemia Following the receipt of minutes from an end-of-phase-II meeting with the FDA, the company said it plans to use measurable residual disease negative complete response as the primary endpoint in the registrational phase III study that is expected to start in mid-2021; data from the study are expected in the second half of 2023
Nervgen Pharma Corp., of Vancouver, British Columbia NVG-291 Protein tyrosine phosphatase sigma inhibitor Diseases related to nerve damage Feedback from the FDA will allow company to run the single ascending-dose portion of the phase I trial in females, followed by the multiple ascending-dose (MAD) portion of the study in post-menopausal females; plans to start study in the second quarter of 2021; FDA wants additional preclinical safety data prior to including males in the phase I program and prior to including premenopausal females in the MAD portion of the study
 
Nicox SA, of Sophia Antipolis, France, and Ocumension Therapeutics Ltd., of Shanghai NCX-470 Nitric oxide-donating prostaglandin analogue Open angle glaucoma or ocular hypertension China’s Center for Drug Evaluation of the NMPA approved the Chinese part of the ongoing phase III Denali study
Novadip Biosciences, of Mont-Saint-Guibert, Belgium NVD‑003 Autologous cell-based osteogenic product Congenital pseudarthrosis of the tibia FDA approved the IND for a pilot study in patients between 2 and 8 years of age 
Pfizer Inc., of New York Lorbrena (lorlatinib) Anaplastic lymphoma kinase inhibitor First-line anaplastic lymphoma kinase-positive non-small-cell lung cancer FDA approved the supplemental NDA, which also converted the accelerated approval into a full approval
The Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis Ministry of Health of Lao People’s Democratic Republic approved the vaccine under the emergency use authorization procedure
The Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis EMA's Committee for Medicinal Products for Human Use started a rolling review of the marketing application
The Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis Ministry of Health of the Republic of Iraq approved the vaccine under the emergency use authorization procedure
The Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis Vaccine was approved in the Democratic Socialist Republic of Sri Lanka under the emergency use authorization procedure
Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Dupixent (dupilumab) Monoclonal antibody targeting the interleukin-4 and interleukin-13 pathways Moderate to severe asthma FDA approved the supplemental BLA for children ages 6 to 11

Notes

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