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Sanofi’s Dupixent Approved in Japan for Chronic Obstructive Pulmonary Disease
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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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Sanofi’s Qfitlia Approved by FDA for Hemophilia A and B Prophylaxis
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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’s mRNA Chlamydia Vaccine Gains FDA Fast Track Designation
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French pharmaceutical giant Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving fast track designation from the US Food and Drug Administration (FDA) for its mRNA vaccine candidate targeting the prevention of chlamydia infection. This designation represents a significant step forward in the development of the vaccine, which is designed to…
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Sanofi’s Tolebrutinib Accepted for FDA Review in Non-Relapsing Secondary Progressive Multiple Sclerosis
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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 and JD Healthcare Collaborate to Enhance Fatty Liver Awareness in China
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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 to Acquire DR-0201 for $600 Million to Advance Myeloid Cell Engager
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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’s Sarclisa Wins New Japan Approval for Multiple Myeloma Combination Therapy
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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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Sanofi and Teva’s Duvakitug Hits Key Milestones in UC and CD Study at ECCO Congress
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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’s Dupixent Receives Priority Review from FDA for Bullous Pemphigoid Treatment
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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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Sanofi and J&J’s E. coli Vaccine Fails Phase III Study
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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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Sanofi Reports Strong Q4 Growth, Plans EUR 5 Billion Share Buyback
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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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FDA Lifts Clinical Hold on Sanofi’s Cialis Over-the-Counter Trial
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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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Sanofi’s Sarclisa Meets Co-Primary Endpoints in Phase III IRAKLIA Study for Multiple Myeloma
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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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Alloy Therapeutics and Sanofi Collaborate on CNS Drug Development with AntiClastic Antisense Platform
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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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Sanofi’s Sarclisa Gains NMPA Approval for Multiple Myeloma Treatment in China
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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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Sanofi and SK bioscience Broaden Partnership to Develop Next-Gen Pneumococcal Vaccines
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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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Hainan Boao Lecheng and Sanofi Partner with Paris-Saclay Cancer Cluster for Advanced Cancer Treatments
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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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Sanofi and Corxel Pharmaceuticals Partner for Aficamten in Greater China Rights
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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…
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Sanofi’s Tolebrutinib Earns FDA Breakthrough Designation for Non-Relapsing Secondary Progressive MS
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Sanofi (NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its Bruton’s tyrosine kinase (BTK) inhibitor, Tolebrutinib, for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Phase III HERCULES Study Results Influence FDA DecisionThe FDA’s decision is supported…
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Sanofi Receives FDA Fast-Track Designation for Influenza and COVID-19 Combo Vaccine Candidates
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Sanofi (NASDAQ: SNY) has announced that it has received Fast-Track Designations from the US Food and Drug Administration (FDA) for its combination vaccine candidates aimed at preventing influenza and COVID-19 infections in individuals aged 50 and older. Details of the Combination Vaccine CandidatesOne of the combination vaccine candidates (NCT06695117) pairs…
