Drugs

FDA Issues Complete Response on Subcutaneous Saphnelo

FDA has issued AstraZeneca a complete response letter declining to approve its BLA for a subcutaneous formulation of Saphnelo (anifrolumab) for treating adult patients with systemic lupus erythematosus (SLE). AstraZeneca says it has submitted the additional information requested by FDA and is continuing to work with the agency to advance the application. The company expects a regulatory decision on the updated submission in the first half of 2026. The intravenously administered version of Saphnelo remains approved and commercially available in the U.S., it says.

The original BLA for subcutaneous Saphnelo was supported by a planned interim analysis of the Phase 3 TULIP-SC trial, which met its primary endpoint. According to the company, the safety profile of subcutaneous anifrolumab was consistent with that of the approved intravenous formulation.

Since the initial U.S. submission, AstraZeneca says it has reported additional data from the completed TULIP-SC trial. Full trial results showed that subcutaneous Saphnelo met the primary endpoint of reducing disease activity, as measured by the British Isles Lupus Assessment Group–based Composite Lupus Assessment at Week 52, it notes. Those findings were published in Arthritis & Rheumatology in January 2026.

If approved, the subcutaneous formulation would offer an alternative route of administration for patients with SLE, a chronic autoimmune disease that affects an estimated 3.4 million people worldwide and is associated with significant morbidity and long-term organ damage.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome