In a letter to the National Union of Food Supplements, the Direction générale de la consommation, de la concurrence et de la répression des fraudes (DGCCRF) outlined that supplements can use the term so long […]
Leveraging a year of important research updates, funding rounds, and academic papers, this report compiles the most significant industry news pertaining to microbiome drug development in 2022. It finds that the regulatory approval of three […]
Today, the U.S. Food and Drug Administration approved Rebyota, the first fecal microbiota product approved by the agency. Rebyota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years […]
Proge Farm, an Italian pharmaceutical company, has made microbiome history with its recently approved therapeutic and will now be able to market its drug based on Lactobaccilus plantarum P 17630. The company obtained authorization from […]
Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for investigational oral microbiome therapeutic SER-109 for […]
Ferring Pharmaceuticals, Inc. has edged ahead in the race to bring the first microbiome-based drug to market in the United States, with its product REBYOTA receiving the thumbs up from the FDA’s Vaccines and Related […]
Ferring Pharmaceuticals today announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) issued a positive vote for RBX2660, an investigational microbiota-based live biotherapeutic studied for its potential […]
Key studies in the last decade have shown that the gut microbiome, the collection of hundreds of bacterial species that live in the human digestive system, influences neural development, response to cancer immunotherapies, and other […]
First described in the 4th Century in China, practiced since the 1950’s and re-discovered relatively recently [1][2], Fecal Microbiota Transplantation (FMT) or simply Fecal Transplant is a therapeutic approach in which more or less processed […]
