The Microbiome Business & Science Briefing
MicrobimeTimes
Reporting on The Latest Microbiome Business & Scientific Developments
TRENDING
From Discovery to Disease Prevention: How the Biose–Siolta Partnership is Advancing a New Generation of Live Biotherapeutics• A pioneering gut bacterium passes Europe’s food-safety review under the EU Novel Food Regulation• Stanford’s AI Designed Bacteriophages: Ushering in the Next Phase in IP Strategy for Phage Companies?• Breathing Engineered Bacteria: A New Approach to Treating Lung Disease• Vedanta Biosciences Secures $60 Million in Funding Ahead of Pivotal Phase 3 Data• Gut fungi may hold the key to treating Asthma worldwide•

Category: Regulatory & Policy

FDA Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
Editor's Choice

FDA Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms

MAR 13, 2020
Doctors Come Together at FDA During C.diff Awareness Month, Advocate for Treatments
Pharma & Human Health

Doctors Come Together at FDA During C.diff Awareness Month, Advocate for Treatments

NOV 18, 2019
FDA Issues Important Safety Alert for Use of FMT after Serious Adverse Reactions
Pharma & Human Health

FDA Issues Important Safety Alert for Use of FMT after Serious Adverse Reactions

JUN 15, 2019
BioCompute and WHISE-Embleema Launch Framework for FDA Drug Submissions
Pharma & Human Health

BioCompute and WHISE-Embleema Launch Framework for FDA Drug Submissions

MAY 15, 2019
Seres Therapeutics First Quarter Financial Results and Clinical Pipeline Progress
Finance

Seres Therapeutics First Quarter Financial Results and Clinical Pipeline Progress

MAY 5, 2019
Finch Therapeutics Receives Fast Track Designation for the Investigation of Microbiota Treatment for Children with Autism Spectrum Disorder
Gut-Brain Axis & Mental Health

Finch Therapeutics Receives Fast Track Designation for the Investigation of Microbiota Treatment for Children with Autism Spectrum Disorder

MAY 1, 2019
MTIG Position Statement on FMT Regulations
Pharma & Human Health

MTIG Position Statement on FMT Regulations

MAR 25, 2019
On Intended Use – the Alpha & Ωmega of Defining Regulatory Status
Pharma & Human Health

On Intended Use – the Alpha & Ωmega of Defining Regulatory Status

MAR 5, 2019
EMA Rules On Omega-3 Medicinal Products – Useful Parallels for the Pharmabiotics Industry
Editor's Choice

EMA Rules On Omega-3 Medicinal Products – Useful Parallels for the Pharmabiotics Industry

DEC 21, 2018
Synthetic Biologics Announces Positive Outcome of End-of-Phase 2 Meeting with FDA on SYN-004 (ribaxamase) Development
Clinical & Manufacturing

Synthetic Biologics Announces Positive Outcome of End-of-Phase 2 Meeting with FDA on SYN-004 (ribaxamase) Development

NOV 22, 2018
Reading Between the Lines: What the FDA Public Workshop Really Tells Us About the Regulation of Microbiome-Based Products
Editor's Choice

Reading Between the Lines: What the FDA Public Workshop Really Tells Us About the Regulation of Microbiome-Based Products

OCT 3, 2018