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Editor’s Choice

Editor's Choice

“Probiotics” Green-lit for market-usage by French Authorities

January 25, 2023 Microbiome Times

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 […]

Editor's Choice

Microbiome Drug Development: 2022 in Review

December 30, 2022 Microbiome Times

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 […]

Editor's Choice

Exclusive Interview with Ken Blount, VP Microbiome Research at Ferring Pharmaceuticals

December 22, 2022 Microbiome Times
Editor's Choice

FDA Approves First Fecal Microbiota Product

December 1, 2022 Microbiome Times

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 […]

Editor's Choice

Proge Farm claims Europe’s first regulatory approval for a microbiome-based therapeutic

November 29, 2022 Microbiome Times

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 […]

Editor's Choice

Seres Therapeutics Announces FDA acceptance of Biologics License Application For Ser-109

October 28, 2022 Microbiome Times

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 […]

Editor's Choice

A microbiome therapeutic is closer than ever to market authorization in the US. What does it mean for the industry?

September 28, 2022 Microbiome Times

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 […]

Editor's Choice

Ferring Receives Positive Vote from U.S. FDA Advisory Committee for RBX2660

September 23, 2022 Microbiome Times

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 […]

Editor's Choice

Stanford researchers construct most complex, complete synthetic microbiome

September 9, 2022 Microbiome Times

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 […]

Editor's Choice

Fecal Microbiota Transplantation (FMT): Global Industry and Regulatory Overview

June 27, 2022 Microbiome Times

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 […]

Editor's Choice

Validation of the predictive role of A.muciniphila for response and resistance to PD1 blockade in non small cell lung cancers

April 15, 2022 Microbiome Times

 

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Editor’s Choice

  • “Probiotics” Green-lit for market-usage by French Authorities
    January 25, 2023
  • Microbiome Drug Development: 2022 in Review
    December 30, 2022
  • Exclusive Interview with Ken Blount, VP Microbiome Research at Ferring Pharmaceuticals
    December 22, 2022
  • FDA Approves First Fecal Microbiota Product
    December 1, 2022
  • Proge Farm claims Europe’s first regulatory approval for a microbiome-based therapeutic
    November 29, 2022
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