News

Sutro Biopharma, Inc., a company specializing in next-generation antibody drug conjugates (ADCs), has announced a new collaboration with the U.S. Food and Drug Administration (FDA) to…
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Sanofi has announced an agreement to acquire London-based biotechnology company Vicebio Ltd, expanding its presence in the respiratory vaccine space. The deal brings with it a promising…
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ProMIS Neurosciences announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead Alzheimer’s disease (AD) therapeutic candidate, PMN310.…
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AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. have announced that China’s Center for Drug Evaluation (CDE) has approved their lead candidate, AHB-137, to proceed into a…
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Sarepta Therapeutics, a leader in precision genetic medicine for rare diseases, announced it has voluntarily and temporarily halted all shipments of ELEVIDYS (delandistrogene…
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Johnson & Johnson has officially submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for icotrokinra, an investigational first-in-class…
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AstraZeneca announces $50 billion of investment in the United States by 2030, building on America’s global leadership in medicines manufacturing and R&D. This investment is expected…
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Rocket Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A601, the company’s…
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Aldeyra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its resubmitted New Drug Application (NDA) for reproxalap, a first-in-class…
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Astellas Pharma Inc. announced the signing of a memorandum of understanding (MoU) with the Korea Institute of Startup and Entrepreneurship Development (KISED), a government-backed…
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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab for the…
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AlzeCure Pharma AB (publ), a Swedish pharmaceutical company focused on treatments for nervous system disorders including Alzheimer’s and pain, announced that the U.S. Food and Drug…
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The U.S. Food and Drug Administration (FDA) has granted fast track designation to SAR446597, a one-time intravitreal gene therapy developed by Sanofi for the treatment of geographic…
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Endeavor BioMedicines, a clinical-stage biotech company focused on life-threatening diseases, announced that its investigational therapy taladegib (ENV-101) has been granted Orphan Drug…
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GSK announced that the U.S. Food and Drug Administration (FDA) has approved a new prefilled syringe presentation of Shingrix, the company’s vaccine for the prevention of shingles…
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Thermo Fisher Scientific and Sanofi have announced an expansion of their strategic partnership, aimed at boosting domestic pharmaceutical manufacturing in the United States. As part of…
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Repare Therapeutics has entered into an exclusive worldwide licensing agreement with Swiss biopharmaceutical company Debiopharm International for lunresertib, a first-in-class precision…
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Boehringer Ingelheim and LEO Pharma have entered an exclusive global license and transfer agreement to commercialize and further develop SPEVIGO (spesolimab), a monoclonal antibody…
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Vertex Pharmaceuticals has announced a broad reimbursement agreement with NHS England for its cystic fibrosis (CF) treatment ALYFTREK (deutivacaftor/tezacaftor/vanzacaftor), following a…
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Otsuka Pharmaceutical Co., Ltd. has signed an asset purchase agreement with Swedish biotech firm Cantargia AB to acquire global rights to CAN10, a promising antibody drug candidate…
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