Outlook Therapeutics Announces UK MHRA Marketing Authorization of LYTENAVA™ (bevacizumab gamma)

Goodwin
Contact

Goodwin

On July 08, 2024, Outlook Therapeutics announced it received marketing authorization from UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of wet AMD in the UK.  As we previously reported, Outlook Therapeutics received marketing authorization for LYTENAVA™ in the EU on May 28, 2024. With these approvals, LYTENAVA™ is the first and only ophthalmic formulation of bevacizumab to treat wet AMD in the EU and UK.  Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, stated “[w]e are pleased to receive UK approval on the heels of marketing authorization in the EU for LYTENAVA™ (bevacizumab gamma). This milestone achievement is the final regulatory step towards our expected commercial launch in the EU and UK in the first calendar quarter of 2025.”

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:

Goodwin
Contact
more
less

PUBLISH YOUR CONTENT ON JD SUPRA NOW

  • Increased visibility
  • Actionable analytics
  • Ongoing guidance

Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide