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News about "US Food and Drug Administration "
Sunrise Air Receives US FDA Clearance, Expanding Access to At-Home Sleep Apnoea Diagnosis
Sunrise Air, Sunrise Group’s FDA-cleared next-generation home sleep testing device, combines AI-powered analysis and advanced sensor technology to deliver accessible, clinically robust sleep apnoea diagnosis from home.
US Food And Drug Administration | 21/05/2026 | By News Bureau
US FDA Upgrades AI Systems, Launches HALO Data Platform to Modernise Regulatory Operations
FDA unveils Elsa 4.0 AI upgrade and consolidates over 40 data systems into the new HALO platform to streamline workflows, enhance regulatory science and accelerate treatment approvals.
US Food And Drug Administration | 08/05/2026 | By News Bureau | 337
Boston Cell Standards Advances Cancer Testing Tools into FDA Qualification Phase
Boston Cell Standards moves closer to standardising cancer diagnostics as its IHC reference tools enter FDA qualification, aiming to improve accuracy and accelerate therapy development.
U.S. Food And Drug Administration | 29/04/2026 | By News Bureau
U.S. Food and Drug Administration accepts sBLA for Ziihera with Priority Review, backed by Phase III data showing improved outcomes in HER2-positive advanced gastric and gastroesophageal cancers.
U.S. Food And Drug Administration | 29/04/2026 | By News Bureau
Johnson & Johnson Secures FDA Priority Review for Imaavy in Rare Blood Disorder
Johnson & Johnson moves closer to delivering a first-in-class treatment for Warm Autoimmune Haemolytic Anaemia with FDA Priority Review for Imaavy.
U.S. Food And Drug Administration | 28/04/2026 | By News Bureau
US FDA Approves CAPLYTA (lumateperone) sNDA for Schizophrenia Relapse Reduction
US Food and Drug Administration (FDA) approves CAPLYTA (lumateperone) sNDA for schizophrenia, showing a 63 percent reduction in relapse risk and 84 percent relapse-free patients over six months, with strong long-term safety and stability data.
US Food And Drug Administration | 28/04/2026 | By News Bureau
Thryv Therapeutics Advances THRV-1268 Programme with Phase II/III Trial and FDA Fast Track Status
Thryv Therapeutics initiates Phase II/III clinical testing and secures FDA Fast Track status for THRV-1268, advancing a potential first-in-class therapy for Long QT Syndrome.
U.S. Food And Drug Administration | 27/04/2026 | By News Bureau
Lupin Launches Diabetes Drug Combination in the US
Lupin launches dapagliflozin and metformin extended-release tablets in the US, offering a bioequivalent and cost-effective alternative for type 2 diabetes management.
U.S. Food And Drug Administration | 22/04/2026 | By News Bureau | 102
Roche Secures FDA Review for Lupus Drug Gazyva
Roche’s Gazyva moves closer to approval for systemic lupus erythematosus after FDA accepts application backed by Phase III trial results showing improved disease control and remission rates.
U.S. Food And Drug Administration | 22/04/2026 | By News Bureau
OS Therapies files patent for immune-response biomarker linked to cancer immunotherapy
New data from the Phase IIb trial of OST-HER2 shows distinct immune signatures tied to improved survival outcomes, supporting accelerated approval discussions with global regulators.
U.S. Food And Drug Administration | 20/04/2026 | By News Bureau
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