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FDA Qualifies First AI Tool to Accelerate Liver Disease Drug Development
The U.S. Food and Drug Administration (FDA) has qualified the world’s first artificial intelligence tool designed to speed up drug development for liver disease.
Zydus to Commercialise Keytruda Biosimilar FYB206 in US and Canada
Zydus Lifesciences has entered into an exclusive licensing agreement with Germany-based Formycon AG to commercialise FYB206, a biosimilar of the immunotherapy drug Keytruda (pembrolizumab), in the United States and Canada.
FDA Qualifies PathAI's AIM-MASH as First AI Tool for MASH Clinical Trials
PathAI has achieved a regulatory milestone with the FDA qualifying its AIM-MASH AI Assist as the first AI-powered tool for MASH clinical trials. The qualification follows the EMA CHMP’s endorsement earlier this year, reinforcing PathAI’s leadership in advancing AI-driven histopathology solutions across American and European drug-development framework.
Amneal Gets FDA Approval for Epinephrine Vials
The FDA has approved Amneal’s epinephrine injection in both single- and multi-dose vials, strengthening the company’s injectables portfolio with a critical medicine widely used in hospitals for emergency and perioperative care.
Terns Prices Upsized USD 650 Million Public Offering
Terns plans to use the proceeds to advance research and clinical development of its pipeline, including TERN-701, support early commercial launch preparations, and fund working capital and general corporate needs.
Yao Pharma and Pfizer Sign Exclusive Collaboration Deal
Yao Pharma has entered into an exclusive global licensing agreement with Pfizer, granting rights to develop, manufacture, and commercialise its oral small-molecule GLP-1 receptor agonists, including lead candidate YP05002. The partnership aims to advance next-generation metabolic therapies with worldwide reach.
Hikma has launched TYZAVAN in the US, introducing a glycopeptide antibacterial in pre-filled, ready-to-use bags designed to streamline hospital workflows and support faster and safer treatment.
Covestro and Allmed Partner to Recycle Artificial Kidney Filters
Covestro and Allmed have launched a feasibility study to explore recycling pathways for artificial kidney filters, bringing together Kimal, hospitals, and recycling partners to build a full medical plastics recycling ecosystem.
High-Impact HDV Candidate Drives Mirum's 620 Million USD Acquisition of Bluejay
Mirum Pharmaceuticals, Inc., a leading rare disease company, has entered a definitive agreement to acquire Bluejay Therapeutics, a privately held biotechnology firm focused on viral and liver diseases.
L'Oreal to Double Its Equity Stake in Galderma as Strategic Partnership Deepens
Galderma Group AG, the pure-play leader in the dermatology category, announced that L’Oréal Groupe plans to increase its equity investment in the company by acquiring an additional 10 percent stake from Sunshine SwissCo GmbH, a consortium led by EQT, the Abu Dhabi Investment Authority (ADIA), and Auba Investment Pte. Ltd. as the sellers.
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