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FDA Approves SPRAVATO (esketamine) as First and Only Monotherapy for Treatment-Resistant Depression…

Jan 23, 2025
Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO (esketamine) CIII nasal spray, making…
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Junshi Biosciences Announces Commercialization Partnership with LEO Pharma for Toripalimab in Europe

Jan 22, 2025
Shanghai Junshi Biosciences Co., Ltd, a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its…
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Dyne Therapeutics’ DYNE-101 Granted FDA Fast Track Designation for Myotonic Dystrophy Type 1

Jan 22, 2025
Dyne Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DYNE-101 for the treatment of myotonic dystrophy type 1 (DM1).…
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Catalent Announces Collaboration with Galapagos to Further Expand Galapagos’ Decentralized CAR-T…

Jan 22, 2025
Catalent, Inc., a leader in enabling the development and supply of better treatments for patients worldwide, announced a strategic collaboration with Galapagos NV (Euronext &…
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Axcynsis Receives FDA Clearance for IND of AT03-65, CLDN6-Targeting ADC

Jan 16, 2025
Axcynsis Therapeutics Pte Ltd ("Axcynsis"), a privately held biopharmaceutical company specialized in delivering Antibody Drug Conjugates (ADCs) with breakthrough potential, proudly…
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FDA Approves Lilly’s Omvoh for Crohn’s Disease, Expanding IBD Treatment Options

Jan 16, 2025
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease…
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AbbVie and Simcere Zaiming Partner to Develop Trispecific Antibody for Multiple Myeloma

Jan 16, 2025
AbbVie and Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group Ltd announced an option to license agreement to develop SIM0500, an investigational new drug candidate. SIM0500…
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Be Bio Announces Closing of $92M Series C Financing and Completes Transition to a Multi-Program,…

Jan 16, 2025
Be Biopharma, Inc. announced the closing of its $92M Series C financing. The round includes participation from new investor Nextech with existing investors including ARCH Venture…
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REGENXBIO and Nippon Shinyaku Form Exclusive Partnership to Develop RGX-121 and RGX-111 for MPS…

Jan 16, 2025
REGENXBIO Inc. and Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) announced a strategic partnership for the development and commercialization of RGX-121 for the treatment of…
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Acadia Pharmaceuticals Submits EMA Application for Trofinetide in Rett Syndrome

Jan 16, 2025
Acadia Pharmaceuticals Inc. announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for trofinetide for the treatment…
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