News

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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Merck announced positive topline results from a pivotal Phase 3 trial evaluating its once-daily, oral two-drug regimen doravirine/islatravir (DOR/ISL) in treatment-naïve adults with…
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The European Commission has approved Alvotech and Advanz Pharma’s Gobivaz, the first biosimilar to Simponi (golimumab) authorized in the European Economic Area. The approval covers…
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Arrowhead Pharmaceuticals has secured a major regulatory milestone with the U.S. Food and Drug Administration’s approval of REDEMPLO (plozasiran), marking the company’s first…
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The European Commission has approved Merck’s new subcutaneous formulation of Keytruda, branded as KEYTRUDA SC, making it the first subcutaneous immune checkpoint inhibitor available in…
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The European Commission has approved Insmed’s BRINSUPRI (brensocatib 25 mg tablets) as the first and only authorized treatment for non-cystic fibrosis bronchiectasis (NCFB) in the…
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The U.S. Food and Drug Administration (FDA) has approved AbbVie’s EPKINLY® (epcoritamab-bysp), a subcutaneously administered T-cell engaging bispecific antibody, in combination with…
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Genprex, Inc. has strengthened the intellectual property protection surrounding its lead drug candidate, REQORSA® Gene Therapy, with the announcement that the U.S. Patent and Trademark…
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Johnson & Johnson has announced a definitive agreement to acquire Halda Therapeutics OpCo, Inc., a clinical-stage biotechnology company developing next-generation targeted cancer…
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Biogen announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a unanimous positive opinion recommending approval of a high-dose…
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