News

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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Johnson & Johnson has announced a definitive agreement to acquire Halda Therapeutics, a clinical-stage biotech developing oral, targeted cancer therapies using its proprietary…
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Merus N.V. and Halozyme Therapeutics have entered into a global, non-exclusive collaboration and license agreement to develop and potentially commercialize a subcutaneous formulation of…
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Solve Therapeutics, a clinical-stage biotechnology company developing best-in-class antibody-drug conjugates (ADCs) for solid tumors, has secured $120 million in an oversubscribed and…
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Sofinnova Partners, one of Europe’s leading life sciences venture capital firms, has closed its latest flagship fund, Sofinnova Capital XI, at €650 million ($750 million)—substantially…
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Sarepta Therapeutics has announced significant updates to the U.S. prescribing information for ELEVIDYS, the only approved gene therapy for Duchenne muscular dystrophy (DMD). The…
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The FDA’s approval of KOMZIFTI™ (ziftomenib) represents a significant milestone for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) harboring NPM1 mutations—one…
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Eisai and Biogen announced that the UK Medicines and Healthcare products Regulatory Agency has approved a once-every-four-weeks IV maintenance dosing regimen for Leqembi (lecanemab), an…
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Mangoceuticals has launched MangoRx Direct and PeachesRx Direct, new programs offering customers direct access to FDA-approved GLP-1 medications Zepbound (tirzepatide) and Wegovy…
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MeiraGTx Holdings plc has announced a broad strategic collaboration with Eli Lilly and Company focused on advancing gene therapies for ophthalmic diseases, including a groundbreaking…
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Insilico Medicine, a clinical-stage company pioneering generative AI-driven drug discovery, has announced a new research collaboration with Eli Lilly and Company to jointly develop…
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SanegeneBio, a clinical-stage biotechnology company focused on RNAi therapeutics, has entered a global research and licensing collaboration with Eli Lilly and Company to develop…
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