FDA Approves Amgen's UPLIZNA® (inebilizumab-cdon) for Generalized Myasthenia Gravis (gMG), Expanding Treatment Options for Patients Living with Autoimmune Neuromuscular Disease

New York, Dec. 12, 2025 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) recognizes the U.S. Food and Drug Administration (FDA) approval of Amgen's UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. This is the first and only CD19-Targeted B-Cell therapy approved for gMG. The approval offers patients a new treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses. Read the Amgen press release here.

GlobeNewsWire • Dec 12, 2025

Here's How AMGN Benefits From FDA Nod to Uplizna in Myasthenia Gravis

AMGN gains momentum as Uplizna wins FDA approval for generalized myasthenia gravis, adding a twice-yearly dosing option in a crowded autoimmune market.

Zacks Investment Research • Dec 12, 2025

FDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVIS

UPLIZNA Offers gMG Patients Deep and Durable Symptom Control and Twice-Yearly Dosing* First and Only CD19-Targeted B Cell Therapy Approved in anti-AChR and anti-MuSK Ab+ gMG THOUSAND OAKS, Calif. , Dec. 11, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive.

PRNewsWire • Dec 11, 2025

AMGEN ANNOUNCES 2026 FIRST QUARTER DIVIDEND

THOUSAND OAKS, Calif. , Dec. 9, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $2.52 per share dividend for the first quarter of 2026.

PRNewsWire • Dec 9, 2025

Here is What to Know Beyond Why Amgen Inc. (AMGN) is a Trending Stock

Amgen (AMGN) has received quite a bit of attention from Zacks.com users lately. Therefore, it is wise to be aware of the facts that can impact the stock's prospects.

Zacks Investment Research • Dec 5, 2025

Why Is Amgen (AMGN) Up 8% Since Last Earnings Report?

Amgen (AMGN) reported earnings 30 days ago. What's next for the stock?

Zacks Investment Research • Dec 4, 2025

Amgen Inc. (AMGN) Presents at Evercore 8th Annual Healthcare Conference Transcript

Amgen Inc. (AMGN) Presents at Evercore 8th Annual Healthcare Conference Transcript

Seeking Alpha • Dec 3, 2025

Amgen Inc. (AMGN) Presents at Citi Annual Global Healthcare Conference 2025 Transcript

Amgen Inc. (AMGN) Presents at Citi Annual Global Healthcare Conference 2025 Transcript

Seeking Alpha • Dec 3, 2025

30% of the S&P 500 Is Mag 7 Tech Stocks, but This ETF Refuses to Own a Single One

The Magnificent 7 AI tech stocks have served as the rocket fuel propelling the S&P 500 on its bull run over the past few years.

24/7 Wall Street • Dec 2, 2025

AMGN Up Almost 16% in a Month: Should You Buy, Sell or Hold the Stock?

Amgen's nearly 16% surge follows strong Q3 results, raised sales guidance and growing momentum across key drugs and biosimilars.

Zacks Investment Research • Dec 1, 2025