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Johnson & Johnson Just Got a Big FDA Win

The Motley Fool·08/27/2026 05:50:00
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Key Points

  • Imaavy can be used to treat patients aged 12 and older with warm autoimmune hemolytic anemia (wAIHA), a rare blood disease.

  • It's the second FDA win for JNJ in as many months.

Healthcare giant Johnson & Johnson (NYSE: JNJ) racked up another win this week from the U.S. Food and Drug Administration.

The regulator approved JNJ's drug Imaavy to treat patients 12 and older who have a rare life-threatening condition called warm autoimmune hemolytic anemia (wAIHA), in which autoantibodies attack red blood cells, leading to severe anemia and fatigue. Between one and three new people per 100,000 are affected by wAIHA each year, and about 1 in 8,000 people live with the condition, according to JNJ.

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A patient receiving drugs through an IV.

Image source: Getty Images.

It's the second FDA win in as many months for JNJ. In July, the company won FDA approval for its dual-energy ablation catheter, which can deliver radiofrequency and pulsed field energy to treat atrial fibrillation, a common heart rhythm disorder.

Johnson & Johnson, of course, is a household name in the U.S., as its products -- from baby powder to Band-Aids -- are well known in every American household. The company spun off the consumer business in 2023 and now operates two major divisions: medical technology equipment and pharmaceuticals.

It's done very well in recent years. As a result, JNJ's share price is up 51% over the past 52 weeks, significantly outperforming the broader market, which is up about 19% over that time, as measured by the S&P 500 index.

Matthew Benjamin has no position in any of the stocks mentioned. The Motley Fool recommends Johnson & Johnson. The Motley Fool has a disclosure policy.