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Regeneron gets FDA acceptance to review expanded label for Eylea HD
Regeneron Pharmaceuticals (NASDAQ:REGN) said on Thursday that the U.S. FDA will be reviewing the supplemental biologics ...
Pharmaceutical Technology on MSN3d
FDA to review Regeneron’s sBLA for aflibercept injection 8mg
The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application ...
Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application
EYLEA ® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion ...
CURE3d
FDA sBLA Submitted for Anktiva Plus BCG in Papillary Bladder Cancer
A supplemental Biologics License Application has been submitted to the FDA for Anktiva plus BCG in papillary NMIBC.
Ophthalmology Times10d
FDA accepts biologics license application from Outlook Therapeutics for ONS-5010 for the treatment of wet AMD
The FDA has accepted the resubmission of the biologics license application (BLA) for ONS-5010 (bevacizumab-vikg) for the ...
Targeted Oncology4d
FDA to Review Nogapendekin Alfa in Bladder Cancer and Lymphopenia
A supplemental biologics license application has been submitted to the FDA for nogapendekin alfa plus Bacillus ...
Outlook Therapeutics® Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD
Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 ISELIN, N.J., April 08, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc.
Yahoo Finance12d
Outlook Therapeutics® Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD
has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment ...