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Lupin Wins FDA Approval for Armlupeg Pegfilgrastim Biosimilar

Dec 2, 2025
Lupin Limited has secured a key regulatory milestone with the U.S. Food and Drug Administration granting approval to Armlupeg™ (pegfilgrastim-unne), the company’s first biosimilar to…
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Regeneron, Tessera Partner on Gene Writing Therapy for AATD

Dec 2, 2025
Regeneron Pharmaceuticals and Tessera Therapeutics have entered into a major global collaboration to advance TSRA-196, an investigational in vivo Gene Writing therapy designed to…
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Lotus Files South Korea NDA for LENZ’s Presbyopia Drug VIZZ

Dec 2, 2025
LENZ Therapeutics and Lotus Pharmaceutical have reached a key regulatory milestone with the submission of a New Drug Application (NDA) to South Korea’s Ministry of Food and Drug Safety…
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FDA Grants Rare Pediatric Disease Status to Solid Biosciences’ FA Therapy

Dec 2, 2025
Solid Biosciences Inc. has received a significant regulatory boost as the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) designation to SGT-212, the…
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Final Days to Save £200 on AI in Drug Discovery 2026 Registration – Offer Ends 5 December

Nov 26, 2025
London, UK – The countdown is on for the 7th Annual AI in Drug Discovery Conference, taking place 9th-10th March 2026 in London. Delegates have until 5th December to secure a £200…
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Telix Opens First APAC Radiopharmaceutical Manufacturing Site in Japan

Nov 25, 2025
Telix Pharmaceuticals has officially opened its first cyclotron-equipped manufacturing facility in the Asia-Pacific region, marking a significant expansion of the company’s…
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Made Scientific, Cellergy Partner to Advance First Mitochondrial Therapy

Nov 25, 2025
Made Scientific, Inc., a U.S.-based clinical and commercial-stage cell therapy contract development and manufacturing organization (CDMO), has announced a new manufacturing partnership…
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Novo Nordisk Alzheimer’s Trials Show No Benefit for Semaglutide

Nov 25, 2025
Novo Nordisk has reported top-line findings from its two major phase 3 Alzheimer’s disease trials, evoke and evoke+, revealing that oral semaglutide did not demonstrate superiority to…
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FDA Approves First Gene Therapy for Broad SMA Patient Population

Nov 25, 2025
The U.S. Food and Drug Administration (FDA) has approved Novartis’ Itvisma® (onasemnogene abeparvovec-brve) for children aged two years and older, as well as teens and adults, living…
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Vaximm Enters Talks for Global License of Oral Cancer Therapy

Nov 24, 2025
OSR Holdings, Inc. announced that its subsidiary Vaximm AG has signed a non-binding term sheet with Swiss-based life sciences investment group BCM Europe AG (BCME) to evaluate a…
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