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FDA Rejects Outlook Therapeutics' Eye Disease Drug, Stock Plummets

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Source: Reuters
FDA Rejects Outlook Therapeutics' Eye Disease Drug, Stock Plummets
Photo: Reuters
TL;DR

The US FDA has declined to approve Outlook Therapeutics' experimental eye disease drug, citing manufacturing issues observed during pre-approval inspections. The drug, ONS-5010, is being developed as an injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases. Outlook Therapeutics will request a meeting with the FDA to address the issues, while the European Medicines Agency is set to begin its review process for the drug.

Topics:businesshealthcare#eye-disease-drug#fda#healthcare#manufacturing-issues#outlook-therapeutics#wet-age-related-macular-degeneration
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  1. US FDA declines to approve Outlook Therapeutics' eye disease drug  Reuters
  2. Outlook Therapeutics® Provides Regulatory Update on FDA Review of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD  GlobeNewswire
  3. FDA Denies Outlook’s Wet AMD Bid, Issues Complete Response Letter  BioSpace
  4. Why Is Outlook Therapeutics (OTLK) Stock Down 78% Today?  InvestorPlace
  5. BREAKING: FDA issues CRL for Outlook Therapeutics' ONS-5010  Ophthalmology Times
  6. View Full Coverage on Google News

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