Company Product Description Indication Status
Agex Therapeutics Inc., of Alameda, Calif., and Imstem Biotechnology Inc., of Farmington, Conn. IMS-001  hES-MSC-based allogeneic cell therapy Multiple sclerosis FDA lifted the clinical hold and cleared the IND
Bellerophon Therapeutics Inc., of Warren, N.J. Inopulse Nitric oxide, inhaled COVID-19 FDA granted emergency expanded access 
Oncology Venture A/S, of Horsholm, Denmark Dovitinib Pan-tyrosine kinase inhibitor Renal cell carcinoma  Attended a pre-NDA meeting with the FDA, in which the FDA indicated it would accept the NDA filing if submitted; the company’s proposal is to seek approval based on noninferiority against the already-approved compound sorafenib (Bayer AG), based on prior phase III trial results 
Viiv Healthcare Ltd., of London Cabenuva Cabotegravir and rilpivirine extended-release injectable suspensions HIV-1 infection Approved by Health Canada
Viiv Healthcare Ltd., of London Vocabria  Cabotegravir HIV-1 infection Health Canada approved it as a short-term addition to Cabenuva

Notes

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

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