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