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US Regulatory Review Update: Tolebrutinib for Non-Relapsing Secondary Progressive MS

Sep 23, 2025
The U.S. Food and Drug Administration (FDA) has extended the target action date for its review of Sanofi’s new drug application (NDA) for tolebrutinib by three months, now set for…
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Minovia Therapeutics’ MNV-201 Granted FDA Fast Track Designation for Myelodysplastic Syndrome

Sep 19, 2025
Minovia Therapeutics Ltd., a clinical-stage biotech focused on mitochondrial diseases and age-related conditions, has announced that the U.S. Food and Drug Administration (FDA) has…
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Novo Nordisk: Ozempic Lowers Heart Attack, Stroke, and Death Risk by 23% vs. Dulaglutide in…

Sep 19, 2025
Novo Nordisk announced new findings from the REACH real-world study demonstrating that Ozempic (once-weekly injectable semaglutide) reduced the risk of major adverse cardiovascular…
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FUJIFILM Biotechnologies Expands Partnership with argenx to Include U.S. Manufacturing

Sep 19, 2025
FUJIFILM Biotechnologies, a leading contract development and manufacturing organization (CDMO), announced a major expansion of its global partnership with immunology company argenx SE.…
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Roche to Acquire 89bio in Merger Deal, Gaining Phase 3 MASH Therapy Candidate

Sep 19, 2025
Roche announced that it has entered into a definitive agreement to acquire 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company developing innovative therapies for…
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Biogen’s ZURZUVAE Approved in Europe as First Treatment for Postpartum Depression

Sep 19, 2025
Biogen Inc. announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE (zuranolone) as a treatment for postpartum depression (PPD) in adults following…
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VectorY and Shape Therapeutics Partner to Develop AAV5-Based Vectorized Antibodies for…

Sep 19, 2025
VectorY Therapeutics and Shape Therapeutics Inc. have announced a new partnership aimed at advancing gene therapies for neurodegenerative diseases. Under an option and license…
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Wheeler Bio and MindImmune Therapeutics Partner to Support Alzheimer’s Prevention Program MITI-101

Sep 18, 2025
Wheeler Bio, a U.S.-based contract development and biomanufacturing organization (CDMO), has signed a partnership agreement with MindImmune Therapeutics to support the development of…
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Novo Nordisk’s Oral Semaglutide Yields 16.6% Weight Loss in Obesity Study

Sep 18, 2025
The New England Journal of Medicine has published the results from Novo Nordisk’s OASIS 4 Phase 3 trial, marking a major advance in obesity treatment with the investigational once-daily…
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GSK to Invest $30 Billion in U.S. R&D and Manufacturing Over Next 5 Years

Sep 18, 2025
GSK plc announced plans to invest $30 billion in the United States over the next five years, focusing on research and development and supply chain infrastructure. This major investment…
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Industry Reports

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Press Releases

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