资讯

The Pharma Letter13 小时
FDA misses decision deadline on Stealth’s Barth syndrome drug
US biotech firm Stealth BioTherapeutics (OTCQB: MITO) is facing renewed uncertainty after the American medicines regulator ...
Fierce Biotech15 小时
UPDATE: FDA misses PDUFA date for Stealth’s ultra-rare disease candidate, delaying ...
An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been ...
BioWorld1 天
Abeona’s rare skin disease gene therapy approved by FDA
Barely a year after the U.S. FDA shackled Abeona Therapeutics Inc.’s cell-based gene therapy with a complete response letter, the agency has approved it for treating a rare and genetic skin disease.
BioPharma Dive1 天
FDA misses approval deadline for biotech’s rare disease drug
The delay for Stealth Biotherapeutics comes amid a heightened focus on the impact FDA job cuts might have on drug reviews.
MPR1 天
FDA Decision on Barth Syndrome Therapy Delayed Again
Elamipretide, a cell-permeable peptide compound, is designed to improve mitochondrial function by targeting the inner mitochondrial membrane where it binds reversibly to cardiolipin.
STAT1 天
This is the end of GLP-1 compounding as we know it
Some telehealth companies that offered compounded GLP-1s have disappeared altogether. Others are pursuing strategies that ...
FDA delays decision on Stealth BioTherapeutics' rare genetic disorder drug
The U.S. Food and Drug Administration has delayed its decision on marketing approval for Stealth BioTherapeutics' treatment ...
Barth Syndrome Foundation Calls for Urgent FDA Action Following Elamipretide Delay
The Barth Syndrome Foundation (BSF), the only patient advocacy organization solely dedicated to saving lives through education, advances in treatments, and finding a cure for Barth syndrome, today ...
STAT1 天
Amid FDA chaos, approval of a rare disease drug gets delayed — again
Stealth BioTherapeutics had expected the FDA to respond on Tuesday to its marketing application for elamipretide to treat ...
Stealth BioTherapeutics Announces Delay in FDA Action Date for Barth Syndrome Application
Stealth BioTherapeutics Inc. (the "Company" or "Stealth"), a clinical-stage biotechnology company focused on the discovery, ...
BioWorld2 天
PDUFA date miss another disappointing delay for Barth drug
Stealth Biotherapeutics Inc., and, more importantly, patients with Barth syndrome, faced another disappointing delay April 29 when the U.S. FDA kicked its approval decision down the road for Stealth’s ...
Johns Hopkins Medicine3 天
5 Foods to Avoid if You Have IBS
Discomfort in the lower gastrointestinal (GI) tract can affect a person's well-being, and it is very common: For instance, about 10% to 15% of Americans suffer from irritable bowel syndrome (IBS), a ...