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) ...

“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 @ ...

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 ...

The U.S. FDA has approved SELARSDI (ustekinumab-aekn ... a proposed biosimilar for Eylea® (aflibercept). Biosimilar User Fee Act (BsUFA) goal dates for approval for these BLAs are in Q4 2025.