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Mashup Score: 4Press Room - Press Releases - 4 day(s) ago
Full results from the pivotal XTEND-Kids study added to the US label, building on the interim data included in the 2023 FDA approval ALTUVIIIO is a first-in-class, high-sustained factor VIII replacement therapy for adults and children with hemophilia A Update exemplifies Sanofi’s continuous commitment to rare blood disorders and to delivering paradigm shifts in the hemophilia treatment landscape Paris, May 10, 2024. The US Food and Drug Administration (FDA) has updated the label for ALTUVIIIO ® [Antihemoph
Source: www.news.sanofi.usCategories: General Medicine News, PayerTweet
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Mashup Score: 4Dupixent® sBLA accepted for FDA Priority Review for treatment of adolescents with chronic rhinosinusitis with nasal polyposis - 4 day(s) ago
* If approved, Dupixent would be the first treatment in the U.S. indicated for adolescents aged 12-17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP), a condition driven in part by underlying type 2 inflammation that obstructs the sinuses and nasal passages and can lead to a loss of sense of smell Paris and Tarrytown, N.Y. May 13, 2024. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA)
Source: www.news.sanofi.usCategories: General Medicine News, PayerTweet-
Today the @US_FDA has accepted for Priority Review our sBLA for our medicine to treat adolescents aged 12 to 17 with chronic rhinosinusitis with nasal polyposis (CRSwNP). Learn more about our most recent news. CC: @Regeneron Learn more ⬇️ https://t.co/q56kTSMpXI https://t.co/soVvSEdZdP
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Mashup Score: 2Press Room - Press Releases - 18 day(s) ago
Paris, April 26, 2024. Twenty-five abstracts across approved and investigational medicines will be presented at this year’s American Thoracic Society (ATS) International Conference taking place from May 17-22 in San Diego. Oral presentations will be given on data for Dupixent ® (dupilumab), in partnership with Regeneron, evaluating its potential as a treatment for patients with chronic obstructive pulmonary disease (COPD) from two landmark phase 3 studies. Notable data presentations for Sanofi’s immunology
Source: www.news.sanofi.usCategories: General Medicine News, PayerTweet-
We’re committed to chasing the miracles of science for patients as we further our research and understanding of #COPD and #asthma. At #ATS2024 we’re presenting 25 abstracts across these chronic respiratory conditions. Learn more ⬇️ https://t.co/I2nzb7MFrL https://t.co/eHPjaiWIPc
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Mashup Score: 1Dupixent® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation - 3 month(s) ago
Priority Review granted based on positive results from two Phase 3 trials If approved, Dupixent would be the only biologic therapy for COPD and the first new treatment approach for the disease in more than a decade Regulatory submissions are also under review in China and Europe Paris and Tarrytown, N.Y. February 23, 2024. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) in a sixth potential
Source: www.news.sanofi.usCategories: General Medicine News, PayerTweet-
#NEWS: The @US_FDA accepted for priority review our application for an investigational COPD medicine. Learn how we’re one step closer to the first biologic treatment option in over a decade for certain patients with COPD. CC: @Regeneron https://t.co/0aDqHiwObm https://t.co/kv3ajJP9PW
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Mashup Score: 5Dupixent® (dupilumab) U.S. label updated with data further supporting use in atopic dermatitis with moderate-to-severe hand and foot involvement - 4 month(s) ago
Data included from first and only Phase 3 trial specifically evaluating a biologic in this difficult-to-treat population Phase 3 trial showed more than twice as many patients treated with Du pixent achieved clear or almost clear skin and nearly four times as many had improvement in itch, compared with placebo PARIS and TARRYTOWN, N.Y., January 16, 2024. The U.S. Food and Drug Administration (FDA) has updated the label for Dupixent ® (dupilumab) in atopic dermatitis, adding efficacy and safety data for
Source: www.news.sanofi.usCategories: General Medicine News, PayerTweet-
The @US_FDA has updated the label for our medicine to include Phase 3 data for patients with atopic dermatitis with moderate-to-severe hand and foot involvement. Learn more about our most recent news. @Regeneron Learn more: https://t.co/WdAOrR3slM https://t.co/YHLx89Z4t1
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Mashup Score: 3
Phase 3 data showed Sarclisa added to carfilzomib, le nalidomide and dexamethasone (KRd) in patients with newly diagnosed, transplant-eligible multiple myeloma resulted in 77% of patients achieving minimal residual disease (MRD) negativity after consolidation therapy, detected with a sensitivity of 10 -5 MRD negativity rate measured at a sensitivity of 10 -6 was 67% for Sarclisa combination therapy Results shared during oral presentation at ASH 2023 plenary scientific session PARIS, December 11, 2023.
Source: www.news.sanofi.usCategories: General Medicine News, PayerTweet-
We’re presenting new data at #ASH23 from a Phase 3 trial of an investigational therapy in people with newly diagnosed transplant-eligible #MultipleMyeloma in collaboration with @EMN_EUMMnet. Read more about the news. https://t.co/SJmB0JMDeu https://t.co/SrXTgfuTki
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Mashup Score: 2
Sarclisa added to bortezomib, lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death compare d with VRd alone First global Phase 3 study to report positive results with an anti-CD38 therapy in combination with VRd in transplant-ineligible patients, reinforcing the potential for Sarclisa as a best-in-class medicine Study results will be submitted for presentation at an upcoming medical meeting and form the basis of a future regulatory submission PARIS, December
Source: www.news.sanofi.usCategories: General Medicine News, PayerTweet-
#NEWS: Our Phase 3 trial for an investigational treatment combination in newly diagnosed #MultipleMyeloma met its primary endpoint. Learn more: https://t.co/PXZqX8KHo3 https://t.co/sKc6lB30un
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Mashup Score: 1Press Room - Press Releases - 1 year(s) ago
Kevzara® (sarilumab) approved by FDA as first and only biologic indicated for patients with polymyalgia rheumaticaCambridge, MA and Tarrytown, N.Y. February 28, 2023. The U.S. Food and Drug Administration (FDA) has approved Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease, in adult patients who have had an inadequate response to…
Source: www.news.sanofi.usCategories: Healthcare Professionals, Latest HeadlinesTweet-
FDA has approved sarilumab (Kevzara) for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. Approval is based on Phase 3 SAPHYR study https://t.co/7GHG2uG9yQ https://t.co/MZ7RYGdDfG
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Mashup Score: 11Press Room - Press Releases - 1 year(s) ago
Kevzara® (sarilumab) approved by FDA as first and only biologic indicated for patients with polymyalgia rheumaticaCambridge, MA and Tarrytown, N.Y. February 28, 2023. The U.S. Food and Drug Administration (FDA) has approved Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease, in adult patients who have had an inadequate response to…
Source: www.news.sanofi.usCategories: Healthcare Professionals, Latest HeadlinesTweet-
FDA has approved sarilumab (Kevzara) for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. Approval is based on Phase 3 SAPHYR study https://t.co/kA9pTauvDP https://t.co/GGlyvQcyat
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Mashup Score: 1Press Room - Press Releases - 3 year(s) ago
Phase 3 trial of Libtayo® (cemiplimab) monotherapy in advanced cervical cancer stopped early for positive result on overall survivalLibtayo is the first immunotherapy to demonstrate improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared to chemotherapyFourth cancer type where Libtayo has positive pivotal data; regulatory submissions planned in…
Source: www.news.sanofi.usCategories: Hem/Oncs, Latest HeadlinesTweet-
Tell me why this isn't news. Phase 3 trial of cemiplimab (Libtayo) monotherapy in advanced cervical cancer extends overall survival; trial stopped early. PR @SanofiUS - https://t.co/QDLytmHHx2 #gyncsm #WomensHealth #cervicalcancer
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#NEWS: The @US_FDA has approved an updated label for our first-in-class #hemophilia A treatment. This is a testament to our ongoing commitment to evolve treatment expectations for the #RareBloodDisorder community: https://t.co/6CRfN8q2CU https://t.co/FhFWenoH4X