Following a successful appeal of a December 2025 CRL, the FDA concluded that Outlook Therapeutics' existing data provided substantial evidence, eliminating the need for new clinical trials.

When approved, ONS-5010/LYTENAVA™ will be the first and only FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust ...

Shares of Outlook Therapeutics OTLK rallied 35.3% on Tuesday after the company announced that the FDA accepted the ...

The agency will now decide whether to approve the drug by July 29, 2026.

For more than 10 years, Dow has been intimately involved in ophthalmic formulation development for various ocular diseases such as cataract, ocular hyphema, dry-eye, age-related macular degeneration, ...

Outlook Therapeutics ( (OTLK) ) has provided an update.

MISSION VIEJO, Calif.--(BUSINESS WIRE)--Today, Wellspring Ophthalmics, a Mission Viejo-based development stage eye care pharmaceutical company focused on innovating an improved, effective dry eye ...

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. NEW ORLEANS — An ophthalmic formulation of bevacizumab ...

Gerresheimer has developed a new dropper insert for ophthalmic formulations that it is showcasing at CPHI 2022 in Frankfurt, Germany. Gerresheimer announced on Oct. 26, 2022 that is has developed a ...

MISSION VIEJO, Calif.--(BUSINESS WIRE)--Today, Wellspring Ophthalmics, a Mission Viejo-based development stage eye care pharmaceutical company focused on innovating an improved, effective dry eye ...

Drug major Cipla on Thursday said it has tied up with CSIR-Central Drug Research Institute to jointly develop a novel ophthalmic formulation for fungal keratitis. The collaboration aims to leverage ...

Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 ISELIN, N.J., April 08, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that ...