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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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