|Allergan plc, of Dublin||Durysta (bimatoprost implant)||Prostaglandin analogue for intracameral administration||Open-angle glaucoma or ocular hypertension||FDA approved NDA|
|Cardiol Therapeutics Inc., of Oakville, Ontario||Cannabidiol formulation||Cannabidiol formulation||Heart failure||Received no objection letter from Health Canada for a phase I study in healthy volunteers|
|Outlook Therapeutics Inc., of Cranbury, N.J.||ONS-5010||Ophthalmic formulation of VEGF inhibitor||Wet age-related degeneration and other retinal diseases||Received tentative FDA approval for trade name of Lytenava (bevacizumab-vikg), subject to further review at the time of planned BLA filing, expected in 2021|
|TG Therapeutics Inc., of New York||Umbralisib||Dual PI3K-delta/CK1-epsilon inhibitor||Follicular lymphoma||FDA granted orphan designation|
|Urovant Sciences, part of New York-based Sumitovant Biopharma Ltd.||Vibegron||β3-adrenoreceptor agonist||Overactive bladder||FDA accepted for review NDA seeking approval to treat patients with symptoms of urge urinary incontinence, urgency and urinary frequency; agency assigned PDUFA date of Dec. 26, 2020, and said it does not currently plan to hold an advisory committee meeting to discuss the application|
|Zydus Cadila Ltd., of Ahmedabad, India||Saroglitazar||Targets PPAR alpha and gamma||Noncirrhotic nonalcoholic steatohepatitis||NDA approved by Drug Controller General of India|
For more information about individual companies and/or products, see Cortellis.