US Food and Drug Administration (FDA)
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Philips secures FDA 510(k) clearance for next-generation reusable SpO₂ clip sensor
The new reusable sensor features internal optical refinements that improve signal quality and measurement consistency.
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Merck secures landmark FDA approval for cholesterol pill Lipfendra
The approval marks the first oral PCSK9 inhibitor, offering patients an alternative to injectable therapies traditionally used to reduce LDL cholesterol levels.
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Novartis secures full FDA approval for Fabhalta in IgA Nephropathy
Fabhalta, a first-in-class complement factor B inhibitor, initially received accelerated FDA approval in 2024 to reduce proteinuria, or excess protein in the urine, a key indicator of kidney damage.
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Orca Bio enters commercial market after FDA approval for Tregzi
Tregzi, also known as Orca-T, is an engineered allogeneic cell therapy used alongside matched-donor hematopoietic stem cell transplantation.
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Vertex Casgevy wins landmark FDA approval for toddlers with SCD and TDT
The expanded label is expected to make about 5,500 additional children in the United States eligible for treatment.
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GSK-Spero Therapeutics’ Utebzi earns FDA approval to combat rising global antimicrobial resistance
More than 3 million cases of complicated UTIs are recorded annually in the United States, and treatment failure affects up to one-third of patients.
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Biogen secures FDA breakthrough status for once-yearly spinal muscular atrophy drug Salanersen
The regulatory decision follows results from a Phase Ib study presented at the 2026 Muscular Dystrophy Association Clinical and Scientific Conference and the 2026 International Scientific Congress on SMA Europe.
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Philips obtains FDA approval for Elevate Plus AI ultrasound enhancement
The newly cleared technology aims to standardize routine ultrasound examinations, reduce variability between operators, and minimize the need for repeat scans.
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Bright Uro expands Glean platform with FDA-cleared abdominal sensor for catheter-free urodynamics
Urodynamics assesses how the bladder, urethra, and sphincters store and release urine to identify causes of leakage or obstruction.
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Sunshine Lake Pharma breaks US barriers with historic FDA approval for LANGLARA
The decision positions LANGLARA as only the fourth insulin glargine product available in the US market, joining established products commercialized by Novo Nordisk, Sanofi and Eli Lilly.