News

AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been recommended for approval in the European Union (EU) for the treatment of adults with resectable non-small…
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Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the…
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WuXi Biologics announced the launch of its innovative technology platform, EffiX, a proprietary E. coli expression system engineered to deliver high yield and exceptional stability in…
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TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (“BBOT”), a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics…
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Magnet Biomedicine, a leading biopharmaceutical company advancing molecular glue discovery with rational selection and design, announced a collaboration and license agreement with Eli…
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Sobi announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gamifant (emapalumab-Izsg) for use in adult and…
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Medigene AG and EpimAb Biotherapeutics, Inc. (EpimAb), announced that the companies have entered a strategic co-development agreement to research and develop off-the-shelf T cell…
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Regeneron Pharmaceuticals, Inc. announced that the  U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for…
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Eli Lilly and Company announced at a press conference in Washington, D.C., plans to bolster its domestic medicine production across therapeutic areas by building four new pharmaceutical…
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Sarclisa, in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult…
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RedHill Biopharma Ltd. announced that it has entered into an exclusive worldwide development and commercialization licensing agreement, excluding North America (the "Agreement"), with…
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Summit Therapeutics Inc. announced a clinical trial collaboration with Pfizer Inc. to evaluate ivonescimab, a novel, investigational PD-1 / VEGF bispecific antibody, in combination with…
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Mirum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved CTEXLI (chenodiol) tablets, a bile acid, for the treatment of adults with…
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Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Opdivo (nivolumab) plus Yervoy …
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Gilead Sciences, Inc. announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s Marketing Authorization Application (MAA) and…
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Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech announced the availability of SELARSDI (ustekinumab-aekn) injection in the U.S., a biosimilar…
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Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its new drug application for zongertinib (BI 1810631) for the treatment of…
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ImmunityBio, Inc. announced the U.S. Food and Drug Administration (FDA) has authorized an expanded access program (EAP) that will bring a vital alternative source of BCG, a…
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Rznomics announced on the 14th that its anticancer drug, RZ-001, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Hepatocellular…
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The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous…
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