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Seeking Alpha27d
EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly ...
If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are ...
Nasdaq27d
Regeneron Announces FDA Acceptance of Priority Review for EYLEA HD® Supplemental Application for Retinal Vein Occlusion Treatment
please talk to your doctor and see the full Prescribing Information for EYLEA HD and EYLEA. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes ...
Seeking Alpha26d
Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application
TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter ...
Morningstar29d
Biocon Biologics Secures Market Entry Date for Yesafili™, an Interchangeable Biosimilar to Eylea®, in the U.S.
It is highly similar to the reference product Eylea® (aflibercept ... of administration described in its Full Prescribing Information. About YESAFILI: The approval for YESAFILI (aflibercept ...
The Manila Times9d
Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab)
The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) ...
Pharmabiz29d
Biocon Biologics secures market entry date for Yesafili, an interchangeable biosimilar to Eylea, in US
As the first-to-file interchangeable biosimilar to Eylea, Yesafili affirms our scientific strength ... and routes of administration described in its full prescribing information.
Yahoo Finance29d
Biocon Biologics Secures Market Entry Date for Yesafili™, an Interchangeable Biosimilar to Eylea®, in the U.S.
It is highly similar to the reference product Eylea® (aflibercept ... of administration described in its Full Prescribing Information.
Morningstar9d
Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab)
AVT06/AVT29 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept ... Please click here for full Prescribing Information for SELARSDI. Teva Pharmaceutical Industries ...