Biotech company Regeneron (NASDAQ:REGN) missed Wall Street’s revenue expectations in Q1 CY2025, with sales falling 3.7% year ...

Schleifer attributed the shift to more patients using off-label bevacizumab ... information over to the FDA posthaste following the rejection, Schleifer said. Eylea HD is already approved ...

Schleifer emphasized the company’s confidence in resolving the FDA issues with the EYLEA HD pre-filled syringe ... Increased market share of off-label Avastin poses a challenge to the anti ...

Q1 2025 Management View CEO Leonard Schleifer highlighted mixed performance in Q1 2025, with challenges in the retinal franchise contrasting with strong growth in other areas. U.S. net sales of EYLEA ...

Eylea’s sales in the United States plunged ... In April 2025, REGN declared a cash dividend of $0.88 per share. The FDA approved a label expansion of Dupixent for the treatment of adults and ...

which is the maximum dosing interval currently indicated in the label). Nonetheless, the FDA accepted the sBLA for Eylea HD injection 8 mg. The sBLA seeks approval for Eylea HD to treat macular ...

The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) ...

Eylea’s sales in the United States plunged 39% year over ... In April 2025, REGN declared a cash dividend of $0.88 per share. The FDA approved a label expansion of Dupixent for the treatment of adults ...

In announcing the latest delay, Stealth CEO Reenie McCarthy noted that the FDA has confirmed postmarketing requirements for the drug and recently initiated labeling discussions ... macular ...

proposed labeling or pre-approval inspection findings. We also recently announced that the FDA had accepted for priority review an sBLA for EYLEA HD to treat macular edema following retinal vein ...