US Food and Drug Administration (FDA)
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Lilly’s Foundayo receives FDA approval to provide needle-free GLP-1 therapy for obesity
When combined with a reduced-calorie diet and regular physical activity, Foundayo helps patients shed excess weight and maintain their progress.
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FDA approves Denali’s Avlayah as first Hunter Syndrome treatment for brain health
Avlayah’s approval validates Denali’s blood-brain barrier shuttle technology, which the company now applies across five clinical programs targeting Alzheimer’s disease, Parkinson’s disease, and Sanfilippo syndrome type A, among others.
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Novo Nordisk secures FDA approval for high-dose wegovy as patent expiry looms
Wegovy HD became the fourth drug to receive FDA approval through the Commissioner’s National Priority Voucher pilot programme.
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Johnson & Johnson’s Icotyde earns FDA approval as first oral peptide for plaque psoriasis
Psoriasis is a chronic autoimmune disorder in which skin cells multiply excessively, creating thick, itchy, scaly patches that affect more than 8 million Americans.
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FDA clears Prodeon Medical’s Urocross expander for non-permanent BPH Treatment
GlobalData analysis projects that the global nephrology and urology device market, which includes BPH treatments, will reach almost USD12 billion in 2035, up from around USD8.6 billion in 2024.
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FDA approves Wellcovorin as first treatment for cerebral folate deficiency
The decision followed a comprehensive systematic review of published literature, which included case reports containing patient-level data and mechanistic studies that demonstrated the treatment’s potential benefits.
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Novartis receives FDA approval for Cosentyx to treat adolescents with Hidradenitis Suppurativa
The expansion of Cosentyx to this population addresses a critical gap in care and demonstrates Novartis’ focus on advancing solutions where the company can make the greatest impact on patient outcomes.
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FDA expands GSK’s Arexvy approval to high-risk adults aged 18-49
The FDA based its approval decision on data from a global Phase IIIb clinical trial demonstrating Arexvy’s effectiveness in the younger adult population.
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FDA clears Philips SmartHeart AI to streamline Cardiac MRI workflows
SmartHeart can cut the number of required breath-holds for basic views by up to 75%, making the examination considerably more comfortable for those being scanned.
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Abbott’s new CardioMEMS HERO Heart Failure Reader wins FDA approval
Abbott engineered the HERO reader to be 60% lighter than its predecessor, making it practical for daily use and convenient enough for patients to carry during travel.