Positive opinion received from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for ONS-5010/LYTENAVA™ (bevacizumab gamma) United Kingdom ( UK ) Marketing Authorization Application (MAA) submitted NORSE EIGHT fully underway in the US; Topline readout

UK submission for national MAA review follows recently received positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) concerning the authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma) ISELIN, N.J.

ISELIN, N.J. , May 09, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it will report

ISELIN, N.J. , May 02, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at

ISELIN, N.J. , April 29, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at

ISELIN, N.J. , April 15, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed

Positive opinion serves as a basis for final decision for potential authorization from the European Commission (EC), expected within 67 days ISELIN, N.J. , March 22, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval

ISELIN, N.J. , March 18, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed

ISELIN, N.J. , March 12, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that a 1-for-20 reverse

NORSE EIGHT underway with first subject dosed and additional clinical sites beginning enrollment Continue to expect planned resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024 Anticipate review decision from European regulators in the first half of CY2024 ISELIN,