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Pharmaceuticals and Drug Development Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis LOS ALTOS, Calif., June 30, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease… Written by Admin July 5, 2025July 5, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development UK antibiotic subscription model key to supporting antibiotic investment For the world to meet the health challenge posed by increasing antimicrobial resistance (AMR), new ways must be found to overcome the market failure that holds back the development of new antibiotics. Critical to this is greater understanding of the factors needed to persuade investors to support research and development (R&D) efforts. The latest report […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom June 23, 2025June 23, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development Tenpoint Therapeutics Ltd. Announces FDA Acceptance of New Drug Application for Brimochol PF for the Treatment of Presbyopia LONDON, United Kingdom and SEATTLE, Wash., June 03, 2025 – Tenpoint Therapeutics, Ltd. (“Tenpoint”), a global, clinical-stage biotechnology company focused on developing groundbreaking treatments to rejuvenate vision in the aging… Written by Admin June 11, 2025June 11, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development 15 years of Op Pangea: over 25 million illegally traded medicines and devices seized in the UK valued at more than £84m This year marks 15 years since the Medicines and Healthcare products Regulatory Agency (MHRA) launched Operation Pangea, an initiative cracking down on medicines crime. Pangea is now coordinated by Interpol, and the MHRA’s Criminal Enforcement Unit (CEU) joined 89 countries for this year’s operation. Working with law enforcement partners, the CEU seized over two million […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom May 30, 2025May 30, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development FDA Extends PDUFA Date of Biohaven's Troriluzole NDA for Rare Disease Spinocerebellar Ataxia NEW HAVEN, Conn., May 14, 2025 /PRNewswire/ — Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the Division of Neurology 1 within FDA’s Office of Neuroscience informed the Company that they are extending the PDUFA date for… Written by Admin May 18, 2025May 18, 2025 Saving Bookmark this article Bookmarked
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Understanding PMDA Validation Rules v5.0 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has always led the charge in ensuring the safety and efficacy of drug development. Their latest update, the PMDA Validation Rules version 5.0, which took effect on April 1, 2024, marks another significant step in this mission. Let’s break down what these new rules mean and […] Written by Admin July 10, 2024July 10, 2024 Saving Bookmark this article Bookmarked
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