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China Approves LEQEMBI IV Maintenance Dosing for Early Alzheimer’s

Oct 1, 2025
Eisai and Biogen announced that China’s National Medical Products Administration (NMPA) has approved a once-every-four-weeks intravenous (IV) maintenance dosing schedule for LEQEMBI…
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FDA Approves TREMFYA for Pediatric Psoriasis and Psoriatic Arthritis

Oct 1, 2025
Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved its biologic therapy TREMFYA® (guselkumab) for use in children aged six years and older…
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Dyne Therapeutics’ DYNE-251 Gains Orphan Drug Status in Japan for Duchenne Muscular Dystrophy

Sep 30, 2025
Dyne Therapeutics announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug designation to DYNE-251, a therapy in development for Duchenne muscular…
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Amgen to Invest $650 Million in U.S. Manufacturing Expansion, Creating Nearly 750 Jobs

Sep 29, 2025
Amgen announced a $650 million expansion of its biologics manufacturing facility in Juncos, Puerto Rico, aimed at increasing drug production and integrating advanced technologies. This…
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FDA Approves Evkeeza for Youngest Children with Rare Genetic Cholesterol Disorder

Sep 29, 2025
Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Evkeeza (evinacumab-dgnb) for treating children aged 1 to under 5 years with homozygous…
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Er-Kim and Sentynl Therapeutics Partner to Expand Access to Rare Disease Treatments in EMEA and…

Sep 26, 2025
Er-Kim, an international pharmaceutical company focused on commercializing novel therapies across the EMEA region, has entered into a distribution agreement with Sentynl Therapeutics,…
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Biostar Pharma’s Utidelone Receives Third Orphan Drug Designation from FDA for Pancreatic Cancer

Sep 26, 2025
Biostar Pharma, the U.S. subsidiary of Beijing Biostar Biopharmaceutical, announced that its core drug candidate, Utidelone, has been granted Orphan Drug Designation (ODD) by the U.S.…
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Eli Lilly Expands Innovation Network with New Gateway Labs Site in San Diego

Sep 26, 2025
Eli Lilly and Company has officially opened its newest Lilly Gateway Labs (LGL) location in San Diego, California, marking an expansion of its shared innovation hubs that support…
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Lonza’s Synaffix Partners with Qurient to Develop Dual-Payload ADC

Sep 26, 2025
Synaffix B.V., a Lonza company focused on advancing clinical-stage antibody-drug conjugate (ADC) technologies, has entered into a licensing agreement with South Korea–based…
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Basilea Secures BARDA Contract for Phase 3 Oral Antibiotic Development

Sep 26, 2025
Basilea Pharmaceutica Ltd, a commercial-stage biopharmaceutical company based in Allschwil, Switzerland, announced that it has been awarded a contract by the U.S. Biomedical Advanced…
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Press Releases

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