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The approval expands the use of the IL-23 inhibitor, previously approved for moderate-to-severe plaque psoriasis, to adults with active psoriatic arthritis.
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The FDA’s expanded approval, supported by Phase 3 TALAPRO-3 results, brings Pfizer’s TALZENNA plus XTANDI combination to an earlier treatment setting for men with HRR-mutated metastatic prostate cancer.
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EMCITATE is the first and only FDA-approved treatment for MCT8 deficiency in the United States, according to Egetis.
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Novo Nordisk’s Awiqli offers children 10 years and older a once-weekly basal insulin alternative, reducing basal injection frequency from seven times per week to one.
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The new programme will coordinate expertise across the FDA’s drug, biologics and medical device centres, with its first initiative focused on advancing clinical trials and drug development for Alzheimer’s prevention.
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Zydus Pharmaceuticals has received US FDA approval for its generic estradiol and levonorgestrel transdermal system, a once-weekly hormone therapy patch used to treat menopausal symptoms and prevent postmenopausal osteoporosis.
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GSK’s Hibsago is the first FDA-approved antisense oligonucleotide (ASO) for treating chronic hepatitis B.
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Viatris is exploring the possibility of partnering with another company in the United States to commercialise RYZUMVI for presbyopia.
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Vantis Vascular’s new 6F CrossFAST Microcatheter System features a larger lumen designed to accommodate a broader range of interventional devices for complex coronary procedures.
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The FDA has accepted Roche’s Biologics License Application (BLA) for vamikibart for the treatment of uveitic macular edema, with an approval decision expected by July 2027.
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