Company Product Description Indication Status
Alimera Sciences Inc., of Atlanta Iluvien (fluocinolone acetonide) Intraocular implant of glucocorticoid receptor agonist Diabetic macular edema; uveitis Iluvien received pricing and reimbursement approvals for both diabetic macular edema and posterior uveitis indications simultaneously
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
Catalyst Pharmaceuticals, Inc., of Coral Gables, Fla. and Kye Pharmaceuticals Inc., of Mississauga, Ontario Firdapse (amifampridine) Potassium channel inhibitor  Lambert-Eaton myasthenic  Challenging Health Canada’s issuance of a Notice of Compliance on Aug. 10 for Medunik’s new drug submission for Ruzurgi (amifampridine)
Hansa Biopharma AB, of Lund, Sweden Idefirix  Cleaves IgG-antibodies Desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor European Commission has granted conditional approval 
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
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

Notes

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