|Can-Fite Biopharma Ltd., of Petach Tikva, Israel||Piclidenoson||A3 adenosine receptor agonist||COVID-19||FDA issued a safe to proceed notice for the IND for a 40-patient phase II study||8/31/20|
|Capricor Therapeutics Inc., of Los Angeles||CAP-1002||Allogeneic cardiac cell therapy||COVID-19||The FDA accepted its IND application for a phase II clinical trial||8/25/20|
|Cstone Pharmaceuticals Co. Ltd., of Suzhou, China||Sugemalimab (CS-1001)||Anti-PD-L1 monoclonal antibody||Relapsed or refractory extranodal natural killer/T-cell lymphoma||FDA issued a study may proceed letter for the IND for a phase II study||8/31/20|
|FSD Pharma Inc., of Toronto||FSD-201 (ultramicronized palmitoylethanolamide)||Anti-inflammatory||COVID-19||Submitted an IND to the FDA for a phase II study testing 2 dose levels of the drug||8/31/20|
|Gilead Sciences Inc., of Foster City, Calif.||Veklury (remdesivir)||Antiviral||COVID-19||FDA expanded the EUA to include all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19||8/31/20|
|Hifibio Therapeutics Inc., of Cambridge, Mass.||HFB-30132A||COVID-19 spike glycoprotein inhibitor; ACE2 inhibitor||COVID-19||Submitted an IND for phase I ascending dose study||8/26/20|
|Laurent Pharmaceuticals Inc., of Montreal||LAU-7b||Oral formulation of synthetic retinoid fenretinide||COVID-19||FDA approved the start of a phase II study||8/27/20|
|Revive Therapeutics Ltd., of Toronto||Bucillamine||Xanthine oxidase inhibitor||COVID-19||Submitted its clinical trial protocol for IRB approval; exploring the FDA expanded access program||8/26/20|
|Revive Therapeutics Ltd., of Toronto||Bucillamine||Xanthine oxidase inhibitor||Mild to moderate COVID-19||Phase III study received institutional review board approval||8/31/20|
|Sirtex Medical US Holdings Inc., of Woburn, Mass.||SIR-Spheres Y-90||Resin microspheres||Liver cancer||China's National Medical Products Administration granted a notice of drug clinical trial approval||8/27/20|
|Sound Pharmaceuticals Inc., of Seattle||Ebselen (SPI-1005)||Glutathione peroxidase stimulator||Moderate or severe COVID-19||FDA allowed the start of 2 phase II studies of 120 adults||8/31/20|
|TLC Biopharmaceuticals Inc., of South San Francisco and 3Sbio Inc., of Shenyang, China||Ampholipad (amphotericin B liposome)||Complex generic||Systemic fungal infections||NMPA's Center for Drug Evaluation accepted its marketing authorization application for Ampholipad||8/26/20|
|Xortx Therapeutics Inc., of Calgary, Alberta||XRx-101 (oxypurinol)||Xanthine oxidase inhibitor||Acute kidney injury associated with COVID-19||Requested a pre-IND meeting with the FDA||8/31/20|
The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.
For more information about individual companies and/or products, see Cortellis.