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

RxDx assay as a companion diagnostic to identify c-Met protein expression in non-squamous NSCLC patients eligible for treatment with Emrelis.

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) in all presentations matching the reference product, effective as of April ...

“The FDA’s confirmation of full interchangeability ... AVT06/AVT29 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept) 2 mg dose, which binds vascular ...

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 ...

Exclusive-US FDA Asks Some Fired Pharma User Fee Negotiation Staff to Return By Patrick Wingrove (Reuters) -The U.S. Food and Drug Administration is asking some of its recently fired staff ...

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 @ ...

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 ...

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 ...