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Sanofi (EPA: SAN, NASDAQ: SNY) announced that it has received approval from Japan’s Ministry of Health, Labour and Welfare for Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. This marks a significant expansion of Dupixent’s therapeutic…
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France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval from the US Food and Drug Administration (FDA) for Qfitlia (fitusiran). This antithrombin-lowering (AT) therapy is now approved for routine prophylaxis to prevent or reduce bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A…
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that a market filing for its tolebrutinib as a treatment for non-relapsing secondary progressive multiple sclerosis (nrSPMS) has been accepted for review by the US FDA. The agency is expected to make its decision by September 28, 2025. A regulatory submission is also under…
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Opella, the consumer health business of French giant Sanofi (EPA: SAN, NASDAQ: SNY), held a collaboration press conference with JD Healthcare, a unit of China’s e-commerce giant JD.com (NASDAQ: JD), in Beijing this week. The collaboration aims to jointly enhance public awareness of fatty liver through activities such as doctor-patient…
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Sanofi (EPA: SAN, NASDAQ: SNY) announced plans to acquire DR-0201, a bispecific myeloid cell engager (MCE) targeting CD20, through the acquisition of its developer, Dren Bio, Inc. The deal underscores Sanofi’s commitment to expanding its portfolio in autoimmune diseases with a novel therapeutic approach. Deal StructureSanofi will pay an upfront…
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a new indication for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adult patients with newly diagnosed multiple myeloma (NDMM). This marks the fourth treatment regimen approved for Sarclisa in…
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China’s Center for Drug Evaluation (CDE) announced the inclusion of Beijing Chiral Tech’s generic version of Sanofi Genzyme’s Cerdelga (eliglustat) in the patient-centered rare disease drug development pilot program, known as the Care Plan. The move aims to accelerate access to affordable treatments for rare diseases. Drug ProfileEliglustat, a glucosylceramide…
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Sanofi (EPA: SAN, NASDAQ: SNY) and Teva Pharmaceutical Industries Ltd (NYSE: TEVA) presented Phase IIb data for duvakitug, their experimental monoclonal antibody targeting TL1A, at the 20th European Crohn’s and Colitis Organisation (ECCO) Congress. The RELIEVE UCCD study evaluated the drug in moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD),…
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that the US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Dupixent (dupilumab) for the treatment of adults with bullous pemphigoid (BP) and granted it priority review status. The FDA is expected to make its decision by June…
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The U.S. Food and Drug Administration (FDA) has approved Sanofi-Aventis’ (EPA: SAN) Merilog, a biosimilar of Novo Nordisk’s (NYSE: NVO) NovoLog. Merilog, a rapid-acting insulin, is indicated for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. The approval includes both a 3 milliliter (mL) single-patient-use…
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France-based Sanofi (NASDAQ: SNY) and US giant Johnson & Johnson’s (J&J, NYSE: JNJ) vaccine candidate for extraintestinal pathogenic E. coli failed to meet expectations in a Phase III study. An independent data monitoring committee (IDMC) determined that the vaccine was insufficiently effective at preventing invasive E. coli disease (IED) compared…
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French pharmaceutical giant Sanofi (NASDAQ: SNY) reported a strong fourth-quarter performance with 10.3% year-on-year (YOY) growth in net sales in constant currency terms, reaching EUR 10.564 billion ($11 billion). The growth was driven by a 56.5% increase in new pharma launches, a 16% rise in sales of Dupixent (dupilumab), and…
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France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval in the European Union (EU) for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab) in combination with the standard-of-care regimen of bortezomib, lenalidomide, and dexamethasone (VRd). The approval is for the treatment of adult patients with newly diagnosed multiple myeloma…
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France-based Sanofi’s (NASDAQ: SNY, EPA: SAN) Consumer Healthcare unit Opella has announced that the US FDA has lifted a clinical hold on its planned Actual Use Trial (AUT) for Cialis (tadalafil). This move allows Sanofi to initiate the AUT and potentially switch the PDE5 inhibitor from a prescription to an…
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French pharmaceutical giant Sanofi (NASDAQ: SNY, EPA: SAN) has announced that the Phase III IRAKLIA study for its Sarclisa (isatuximab) met its co-primary endpoints when administered subcutaneously (SC) via an on-body delivery system (OBDS) in patients with multiple myeloma (MM). This marks a significant step forward in the treatment of…
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US-based Alloy Therapeutics Inc. has announced a target-specific collaboration and license agreement with Sanofi (NASDAQ: SNY), the French pharmaceutical giant. The partnership aims to leverage Alloy’s neuroscience expertise to develop a novel drug targeting the central nervous system (CNS) based on Alloy’s proprietary AntiClastic Antisense Platform. This technology, launched by…
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Sarclisa (isatuximab) in combination with pomalidomide plus dexamethasone. This approval is for the treatment of adult patients with multiple myeloma who have previously received at least first-line…
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French pharmaceutical major Sanofi (NASDAQ: SNY) and South Korea-based SK bioscience (KRX: 302440) have announced an expansion of their partnership to develop, license, and commercialize next-generation pneumococcal conjugate vaccines (PCVs) targeting both pediatric and adult populations. Milestone in Pediatric Vaccine DevelopmentTheir existing agreement, which aimed to develop and commercialize a…
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The Hainan Boao Lecheng International Medical Tourism Pilot Zone, in collaboration with France’s major Sanofi’s (NASDAQ: SNY) China unit and the Paris-Saclay Cancer Cluster (PSCC), has established a tripartite collaboration aimed at advancing healthcare solutions. This partnership is designed to combine the strengths of each organization to enhance the treatment…
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Global healthcare leader Sanofi (NASDAQ: SNY) and China-based Corxel Pharmaceuticals (CORXEL), formerly known as Ji Xing Pharmaceuticals, have jointly announced an official agreement. Under this partnership, Sanofi is set to acquire exclusive development and commercialization rights to CORXEL’s aficamten in Greater China. The financial details of the deal have not…