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Oyster Point Pharma, Inc.

https://oysterpointrx.com/

Latest From Oyster Point Pharma, Inc.

Keeping Track: US FDA Clears Opioid Seglentis And Anti-Opioid Zimhi; CRLs For Revance, United; Delay For UCB

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Drug Review

Oyster Point Prepares Major Push For New Dry Eye Drug

Execs told Scrip they hope to get Tyrvaya (varenicline) onto formularies and aim for pricing that would make its nasal spray competitive with Restasis and Xiidra.

Approvals Ophthalmic

US FDA’s October Outlook Includes Psoriasis Blockbuster Hopeful, Ophthalmology And Orphans

User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.

Drug Review Advisory Committees

Aerie Misses Quick Path To Dry Eye Approval, But Is Still Moving Forward

AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.

Clinical Trials Drug Approval Standards
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