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Pharmaceuticals and Drug Development Replimune Announces FDA Acceptance of BLA Resubmission of RP1 for the Treatment of Advanced Melanoma WOBURN, Mass., Oct. 20, 2025 (GLOBE NEWSWIRE) — Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration… Written by Admin November 2, 2025November 2, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development Discovery Park welcomes decision to re-join EU Horizon science programme This international collaboration brings together the brightest minds in the world and offers transformational funding that will be vital to drive scientific discovery. Positioned in Kent at the interface of the UK and Europe, Discovery Park is home to a wide range of companies driving scientific development who will benefit from the opportunities this programme […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom October 21, 2025October 21, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development Sentynl Therapeutics Updates On Its NDA for CUTX-101 Solana Beach, CA – OCTOBER 1, 2025 – Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (“Zydus”), announced today that the U.S. Food and Drug… Written by Admin October 9, 2025October 9, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development BRIM closes a $45.8 million rights issue early to accelerate its pipeline of regenerative peptides The fund will be used to accelerate the development of several assets within BRIM’s pipeline, including the ongoing phase 3 trial of lead asset BRM421 for dry eye disease (DED) in the US and the enrollment of the phase 2 trial of BRM424 for neurotrophic keratitis (NK). BRIM will also progress the development of BRM521 […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom September 27, 2025September 27, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development Stealth Biotherapeutics Announces FDA Acceptance of Elamipretide NDA Resubmission NEEDHAM, Mass., Aug. 21, 2025 /PRNewswire/ — Stealth BioTherapeutics, a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction… Written by Admin September 15, 2025September 15, 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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