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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’s Merilog Biosimilar Wins FDA Approval for Diabetes Treatment
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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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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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Sanofi Invests EUR 300 Million in Joint Venture with Orano Med for Next-Generation Radioligand Therapies
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Sanofi (EPA: SAN), a leading French pharmaceutical company, has entered into a strategic agreement with Orano Med, a subsidiary of the French Orano Group, to enhance the development of next-generation radioligand medicines. The collaboration aims to accelerate the growth of radioligand therapies (RLTs) based on lead-212 (212Pb) alpha-emitting isotopes, which…
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Sanofi Commences Negotiations with CD&R for Potential Sale of Opella Stake
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Sanofi (EPA: SAN; NASDAQ: SNY) has initiated negotiations with private equity firm CD&R for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business, marking a significant milestone in the French pharmaceutical giant’s strategic realignment. While no decision has been finalized, Sanofi will provide further updates…
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Sanofi’s Consumer Health Unit Attracts Binding Offers, Potential EUR 15 Billion Deal
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French pharmaceutical giant Sanofi S.A. (EPA: SAN; NASDAQ: SNY) has reportedly received multiple binding offers for its consumer health care (CHC) division, from private equity firms Clayton Dubilier & Rice and PAI Partners, according to sources cited by Bloomberg. The potential deal could value the business at up to EUR…
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Sanofi’s Sarclisa Secures FDA Approval for First-Line Multiple Myeloma Treatment
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Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib,…
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Sanofi Secures Global Rights to Radioligand Therapy AlphaMexi in Deal with RadioMedix and Orano Med
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Sanofi (EPA: SAN; NASDAQ: SNY), a leading French pharmaceutical company, has entered into a significant licensing agreement with US biotechnology firm RadioMedix Inc. and French company Orano Med, securing global rights to a radioligand therapy (RLT). The agreement centers on AlphaMexi (212Pb-DOTAMTATE), a targeted alpha therapy (TAT) that utilizes a…
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Sanofi’s Dupixent Shows Promise in Phase III Trials for Rare Skin Disease and Chronic Hives
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Sanofi (EPA: SAN; NASDAQ: SNY), a leading French pharmaceutical company, has announced positive results from two Phase III clinical trials for its drug Dupixent (dupilumab), indicating its potential for two distinct indications. The first trial, ADEPT, concentrated on the treatment of the rare skin condition bullous pemphigoid (BP), while the…
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Sanofi’s Q2 2024 Results Showcase Robust Growth in Pharma and Consumer Health Divisions
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Sanofi (NASDAQ: SNY; EPA: SAN), the French multinational pharmaceutical company, has reported its financial results for the second quarter of 2024, demonstrating a robust year-on-year growth of 10.2% in global net sales, reaching €10.745 billion (USD 11.64 billion) in constant currency terms. This growth was driven by the company’s Pharma…
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Sanofi to Bolster Hyderabad Facility with $437M Investment, Eyeing Tech Upgrades
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Sanofi (NASDAQ: SNY; EPA: SAN), a leading French multinational pharmaceutical company, has announced plans to significantly expand its global capacity center (GCC) in Hyderabad, India. The company intends to invest EUR 400 million, equivalent to approximately USD 437 million, over a six-year period. This expansion will create an additional 1,600…
