US FDA declines to approve Outlook Therapeutics' eye disease drug

The U.S. Food and Drug Administration has declined to approve Outlook Therapeutics' experimental eye disease drug due to manufacturing issues observed during inspections, causing the company's shares to plummet by 78%.

reuters.com

Relevant topic timeline:

8/28/2023

FDA warns to stop using 2 eye drop products

The FDA is warning consumers to stop using certain brands of eyedrops due to contamination with bacteria, fungus, and unapproved drugs, urging users to check their eye drops and discard them if they are among the affected products.

8/30/2023

EGY, GNS and OTLK among pre-market losers

Outlook Therapeutics plummets 78%, FibroGen declines 23%, and other stocks see significant drops after various earnings releases and study results, while UP Fintech Holding reports positive Q2 results.

8/30/2023

Outlook Therapeutics (NASDAQ: OTLK) Craters 83% on FDA Setback - TipRanks.com

Biopharmaceutical company Outlook Therapeutics experienced a significant decline in stock value after the FDA issued a letter stating that it could not approve the company's application for an investigational drug due to various issues and a lack of evidence.

9/12/2023

FDA Warns 8 Companies Over Marketing Unapproved Eye Drops That Could Cause Harm

The FDA has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drugs, including products that can cause permanent skin and eye discoloration, and may pose a risk to users.