News

Exelixis, Inc. and Merck known as MSD outside of the United States and Canada, today announced that the companies have entered into a clinical development collaboration to evaluate the combination of Exelixis’ investigational tyrosine kinase inhibitor (TKI) zanzalintinib with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a Phase 3 pivotal trial for the treatment of patients with head and neck squamous

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Roche announced today that the United States Food and Drug Administration (FDA) approved Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative

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Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia

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Pharming Group N.V. announces the start of a Phase II, proof of concept, clinical trial evaluating leniolisib in primary immunodeficiencies (PIDs) with immune dysregulation linked to altered PI3Kẟ signaling in lymphocytes.

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Capricor Therapeutics a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, announced today that it has initiated its rolling submission process with the U.S. Food and Drug Administration

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Opencell Technologies, a leading innovator in scalable and continuous cell transfection technology, and Adva Biotechnology, a leader in automated innovative cell manufacturing solutions providing a decentralized, controlled, and efficient manufacturing

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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates

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PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced the U.S. Food and Drug Administration (FDA) has approved a pivotal Investigationa

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Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, and Jiangsu Aosaikang Pharmaceutical Co. Ltd.

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Daiichi Sankyo today announced that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU® (trastuzumab deruxtecan) for the treatment of adult patients with HER2 low (IHC 1+ or IHC 2+/ISH-) or ultralow (IHC 0 with membrane staining) unresectable or recurrent breast cancer.

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