Company Product Description Indication Status
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

Notes

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

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