News

The U.S. Food and Drug Administration (FDA) has appointed Tracy Beth Høeg, M.D., Ph.D., as the acting director of the Center for Drug Evaluation and Research (CDER), marking a…
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The U.S. Food and Drug Administration (FDA) has issued new draft guidance identifying specific drug product types for which six-month non-human primate (NHP) toxicity studies can be…
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Citizen Health has announced a major strategic partnership with UCB, a global biopharmaceutical leader in neurological and autoimmune research, to accelerate drug discovery and…
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IQVIA has announced a major strategic collaboration with Amazon Web Services (AWS), naming the cloud company as its Preferred Agentic Cloud Provider—a move set to accelerate the digital…
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Ionis Pharmaceuticals has announced a major regulatory milestone for its investigational therapy olezarsen, as the U.S. Food and Drug Administration (FDA) has granted it Breakthrough…
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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 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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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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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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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, 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 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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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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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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AstraZeneca announced plans to invest $2 billion to significantly expand its manufacturing presence in Maryland, marking one of the company’s largest U.S. investments to date. The…
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Alkermes plc and Avadel Pharmaceuticals have agreed to revised terms for Alkermes’ acquisition of Avadel, increasing the total potential value of the deal to $22.50 per share. The new…
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Roche announced that the European Commission has granted conditional marketing authorisation for a new subcutaneous (SC) formulation of Lunsumio (mosunetuzumab) for adults with relapsed…
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Novartis has announced a sweeping expansion of its U.S. operations, unveiling plans to establish a new flagship manufacturing hub in North Carolina that will feature full end-to-end…
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Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved EYLEA HD (aflibercept) Injection 8 mg for treating macular edema following retinal vein…
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Moderna, Inc. has announced a major expansion of its U.S. manufacturing network with plans to bring Drug Product (DP) manufacturing to its Moderna Technology Center (MTC) in Norwood,…
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