FDA Approves J&J’s Imaavy for Warm Autoimmune Hemolytic Anemia, the First Therapy Ever Cleared in the Disease

The FDA approved Johnson & Johnson’s Imaavy (nipocalimab-aahu) for warm autoimmune hemolytic anemia, the first therapy ever shown safe and effective in the disease — a standard approval granted under Priority Review that expands the FcRn blocker beyond its April 2025 myasthenia gravis label and hands J&J a first-mover position it will have to defend against several fast-following rivals.

Today’s top developments:

• The FDA approved J&J’s Imaavy (nipocalimab-aahu) for warm autoimmune hemolytic anemia in adults and pediatric patients 12 and older who are or were treated with corticosteroids — the first therapy ever cleared specifically in wAIHA, granted under Priority Review as a standard approval and expanding the FcRn blocker beyond its April 2025 myasthenia gravis label (Pharmaphorum)
• Federal courts rejected Merck’s and AstraZeneca’s challenges to Medicare drug price negotiation — Judge Kollar-Kotelly dismissed Merck’s First and Fifth Amendment claims over Januvia on August 24, days after a Maryland judge threw out AstraZeneca’s aggregation argument — leaving the constitutional campaign all but exhausted after the Supreme Court declined five manufacturers’ appeals in May (Fierce Pharma)
• McKesson agreed to acquire Precision Medicine Group for $2.25 billion, folding its biomarker intelligence, laboratory, CRO, market access and commercialisation stack into McKesson’s Oncology & Multispecialty segment and pushing the distributor further up the value chain into the services biopharma buys around an oncology launch (Pharmaceutical Executive)
• Arch and Population Health Partners — the backers behind Metsera — launched Sentivera with an $83 million financing and in-licensed a Type 2 inflammation small molecule from China’s Haisco for $40 million cash plus ~$36 million in stock, against a $1.5 billion headline that is almost entirely milestone-contingent on an asset with no human efficacy data (Fierce Biotech)
• Employer coverage of GLP-1 weight-loss drugs fell to 60% in 2026 from 72% a year earlier, with 14% of employers having dropped it or planning to for 2027, as firms project a 9.2% healthcare cost increase and name cancer their most acute cost driver, per a Business Group on Health survey (Reuters)