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Astellas Pharma and Pfizer have reported positive topline results from an interim analysis of the Phase 3 EV-304 clinical trial, strengthening evidence that the combination of PADCEV™…
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Takeda Pharmaceutical Company has announced positive topline results from two pivotal Phase 3 clinical trials evaluating zasocitinib (TAK-279), a next-generation oral therapy for adults…
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Johnson & Johnson has secured U.S. Food and Drug Administration approval for RYBREVANT FASPRO™, marking a significant advance in the treatment of epidermal growth factor receptor…
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China’s National Medical Products Administration (NMPA) has approved JASCAYD® (nerandomilast), marking the first new treatment for adults with progressive pulmonary fibrosis (PPF) in…
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China’s National Medical Products Administration (NMPA) has approved two innovative Sanofi therapies—Qfitlia (fitusiran) for hemophilia and Cablivi (caplacizumab) for acquired…
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Pfizer has released compelling new data from its Phase 3 HER2CLIMB-05 clinical trial, showing that the company’s tyrosine kinase inhibitor, TUKYSA® (tucatinib), significantly improved…
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Ionis Pharmaceuticals has received a significant boost in its neurology pipeline with the U.S. Food and Drug Administration granting Breakthrough Therapy designation to zilganersen, the…
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Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has granted expanded approval for Jaypirca (pirtobrutinib) for adults with relapsed or refractory…
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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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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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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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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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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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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 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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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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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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Novartis has announced the opening of a new 10,000-square-foot radioligand therapy (RLT) manufacturing facility in Carlsbad, California — a major step in the company’s $23 billion,…
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