FDA Approval for FEXINIDAZOLE issued to SANOFI

BRIDGEWATER, N.J., March 14, 2025 /PRNewswire/ -- Sanofi announced today the immediate adoption of influenza strains selected by the US Food and Drug Administration (FDA) to advance the manufacturing and delivery of its vaccine portfolio for the 2025-26 flu season in the US. As the world leader in flu vaccines, Sanofi had already begun its annual production of vaccines to ensure that robust supply is ready for the coming season. Strains selected by the FDA match those already used in production by the company to help protect eligible patients against flu and its potentially severe complications. Sanofi plans to begin shipping flu vaccines this summer so that health systems, hospitals, pharm

Issues Letter to Fellow Shareholders Detailing Why Truly Independent Voices – Including a Shareholder Representative – Are Needed in the Dynavax Boardroom Highlights Concerns that Company's Misguided Acquisition Strategy Will Destroy Value and Prevent Dynavax from Maximizing the Benefit of Heplisav for Shareholders and Patients In Deep Track's View, Focusing on Heplisav Could Result in Nearly $2 Billion of Cash Being Returned to Shareholders by the End of 2030 Details Board's Poor Governance, Reactive Entrenchment Maneuvers, and Unwillingness to Work Constructively Believes Its Slate of Director Nominees Would Collectively Bring Valuable Shareholder Perspective and Independence as Well

Six out of 10 infants and newborns in Canada will have access to the protective antibody Beyfortus® for the first time this seasonAccess to Beyfortus® includes infants in remote communities most impacted by respiratory syncytial virus (RSV), in all three territories and northern Quebec and OntarioBeyfortus® demonstrated the ability to reduce the risk of RSV lower respiratory tract infections by 74.5%, including hospitalizations in infants entering their first RSV seasoniTORONTO, Oct. 28, 2024 /CNW/ - Sanofi is pleased to announce Beyfortus® (nirsevimab) will be broadly available for babies born in Ontario, Quebec, Nunavut, Northwest Territories, and the Yukon this fall. The administration of

Goldman initiated coverage of Sanofi with a rating of Neutral and set a new price target of $65.00

Deutsche Bank upgraded Sanofi from Sell to Hold

Argus reiterated coverage of Sanofi with a rating of Buy and set a new price target of $60.00 from $55.00 previously

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For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors (neutralizing antibodies).“Today’s approval of Qfitlia is significant for patients wi

For Immediate Release: February 14, 2025 Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Meri

Submission status for SANOFI-AVENTIS US's drug SOLIQUA 100/33 (SUPPL-14) with active ingredient INSULIN GLARGINE; LIXISENATIDE has changed to 'Approval' on 11/01/2024. Application Category: BLA, Application Number: 208673, Application Classification:

ROCKVILLE, Md., June 6, 2024  /PRNewswire/ -- I-Mab (NASDAQ:IMAB) (the "Company"), a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, today announced the appointment of Dr. Phillip Dennis as Chief Medical Officer. Dr. Dennis, who will join I-Mab effective June 17, 2024, will lead the Company's global clinical development efforts and serve as a member of I-Mab's Executive Leadership Team. "I am pleased to welcome Dr. Phillip Dennis as our Chief Medical

Sanofi hosted the founding ceremony of the homeless futsal club ‘Dream' and organized a friendly match as a part of the Helping Hands program Sanofi employees and ‘Dream' members interacted through the friendly match Sanofi has carried out social responsibility activities targeting the homeless and housing vulnerable groups since 2011 Sanofi in Korea[1], the Korean subsidiaries of the global healthcare company Sanofi, hosted the founding ceremony of the homeless futsal club ‘Dream' together with Dalpengyee, a nonprofit organization, to promote self-sufficiency among the homeless. At the founding ceremony of the ‘Dream', held in Seongsu-dong, Seoul on the 17th, the club's first game

BRIDGEWATER, N.J., Aug. 3, 2022 /PRNewswire/ -- Sanofi announces three appointments to key leadership roles for U.S. General Medicines and its North American Vaccines and Consumer Healthcare businesses. Olivier Bogillot becomes Head of U.S. General Medicines. Bogillot, most recently President of Sanofi France, will lead the business unit responsible for serving the Diabetes, Cardiovascular and Transplant communities effective September 1. Bogillot joined Sanofi in 2015, and has held various positions within the company, including as Executive Director of Global Policy based in the U.S. and Chief of Staff to the CEO. In March 2020, he was appointed President of Sanofi France, where he has led

― Entered into a collaboration and ex-U.S. license agreement with Sanofi for the development and commercialization of losmapimod ― ― On track to report topline data for Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD) in the fourth quarter of 2024 ― ― Industry veteran, Patrick Horn M.D., Ph.D., appointed as chief medical officer ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, toda

― Sanofi receives exclusive rights to commercialize losmapimod in all territories outside the U.S.; Fulcrum retains full U.S. commercialization rights ― ― Fulcrum will receive an upfront payment of $80.0 million, and is eligible to receive $975.0 million in potential milestones, plus royalties on ex-U.S. product sales; parties will share future global development costs 50:50 ― ― Conference call and webcast scheduled for 8:00 a.m. ET today to discuss the collaboration and other recent corporate developments, in conjunction with the first quarter 2024 financial results ― CAMBRIDGE, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a c

Announces co-exclusive licensing agreement with Sanofi to co-commercialize COVID-19 vaccine, develop novel COVID-19-Influenza combination vaccines and develop multiple new vaccines utilizing Novavax's Matrix-MTM adjuvantThis agreement represents a potential multi-billion dollar revenue opportunity for Novavax including:$500 million upfront payment Approximately $70 million equity investment in NovavaxUp to $700 million in COVID-19 and combination product near-term milestones, plus ongoing tiered royalties on product salesUp to $200 million in milestones plus royalties for each new vaccine developed utilizing Novavax's Matrix-MTM adjuvantAnnounces addition of standalone influenza vaccine to P

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