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