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264,271 Results for "sebela pharmaceuticals".
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Press Releases
FDA Approves MIUDELLA®, the First Hormone-Free Copper Intrauterine System (IUS) in the U.S. in Over 40 Years, from Sebela Women’s Health Inc.
February 26, 2025
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9 min read
Press Releases
Sebela Women’s Health Announces Publication of Phase 3 Pivotal Study Results for the Investigational Copper 175 mm² Intrauterine Device (IUD) in Contraception
January 24, 2025
·
7 min read
Drug Development
Sebela Women’s Health Announces Further Positive Data from the Pivotal Phase 3 Study of the Investigational Copper 175 mm² Intra-Uterine Device (IUD)
Sebela Women’s Health Inc., a part of Sebela Pharmaceuticals, today announced additional positive data from the pivotal Phase 3 open-label study of the investigational Copper 175 mm2 intra-uterine device (IUD).
October 30, 2023
·
11 min read
Business
Sebela Pharmaceuticals Announces New Division Named Sebela Women’s Health
Sebela Pharmaceuticals® announced a new division of the company named Sebela Women’s Health along with the appointment of Kelly Culwell, MD, as Head of Research and Development for the division.
November 15, 2022
·
5 min read
FDA
FDA Approves Sebela Pharmaceuticals’ SUFLAVE™ A New Colonoscopy Preparation that Tastes Similar to a Sports Drink
Sebela Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) granted approval of SUFLAVE™ (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution), for colonoscopy preparation in adults.
June 22, 2023
·
9 min read
Business
Sebela Pharmaceuticals® Appoints Victor Parker as Chief Commercial Officer
Sebela Pharmaceuticals, a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women’s health, today announced the appointment of Victor Parker to the position of Chief Commercial Officer.
October 24, 2022
·
3 min read
Business
Sebela Pharmaceuticals® Acquires Exclusive Licensing Rights to Develop and Commercialize Tegoprazan in the U.S. and Canada
Sebela Pharmaceuticals® has entered an exclusive partnership with HK inno.N Corporation to license tegoprazan in the United States and Canada.
October 19, 2022
·
4 min read
Drug Development
Sebela Women’s Health Announces Positive Phase 3 Data for its Investigational, Next-Generation, Hormone-Free, Low-Dose Copper Intrauterine Device (IUD)
Sebela Women’s Health Inc. today announced positive results of a Phase 3 study demonstrating that investigational Copper 175 mm2 IUD met the primary efficacy outcome measurement of prevention of pregnancy through 3 years of use, with a cumulative 3-year Pearl Index (number of pregnancies per 100 women over 1 year) of 0.96 (95% CI, 0.59-1.48) or 99% efficacy.
May 18, 2023
·
8 min read
FDA
Sebela Pharmaceuticals Announces U.S. Launch of SUTAB® Tablets, An Alternative to Liquid Colonoscopy Preparation
Sebela Pharmaceuticals® today announced that SUTAB® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, the first tablet colonoscopy preparation to receive approval from the U.S. Food and Drug Administration (FDA) in over 10 years, is now available in the United States.
January 5, 2021
·
8 min read
BioMidwest
CellMax Life and Sebela Pharmaceuticals Enter Strategic Development and Commercialization Partnership for FirstSight™ Blood Test for Detection of Colorectal Cancer and Pre-Cancer
CellMax Life, a molecular diagnostics company with proprietary technology for pre-cancer and cancer detection blood tests, and Sebela Pharmaceuticals, a market leader in gastroenterology, announce the closing of a strategic development and commercial collaboration agreement, as well as CellMax’s Series C financing.
March 23, 2021
·
9 min read
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