The FDA approved dihydroergotamine (DHE) mesylate injection (Brekiya) to treat acute migraine (with or without aura) and ...

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

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

The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of ...

The US FDA approved sustained-release corticosteroid implants for more serious or longer-lasting conditions, are OZURDEX, RETISERT, and ILUVIEN. Learn more about the diabetic macular edema treatment @ ...

Now, while the FDA hasn’t shared a new expected action date, Stealth says labeling discussions between the agency and Massachusetts biotech are currently underway. “Despite the delay ...

including $307 million from Eylea HD. Also Read: FDA Sets The Countdown: Regeneron’s Eylea HD Could Be Headed For Major Expansion Net product sales of Eylea HD increased in the first quarter of ...

Regeneron Pharmaceuticals stock was among the biggest S&P 500 and Nasdaq decliners Tuesday after the biotech firm reported first-quarter sales—especially those of its key Eylea eye disease drug ...

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 ...