Le Lézard

Accord BioPharma, Inc. Announces FDA Approval of Denosumab Biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu)

Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug ...
Le Lézard

Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US

Shanghai Henlius Biotech, Inc. (2696.HK), and Organon today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab-dpzb) ...
Ophthalmology Times

Regeneron's EYLEA HD injection 8 mg approved by FDA for the treatment of macular edema following RVO

The US Food and Drug Administration (FDA) has approved aflibercept injection 8 mg (EYLEA HD) from Regeneron Pharmaceuticals ...

EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications

First and only FDA-approved treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period Monthly dosing ...