FDA denies Barth syndrome drug approval, suggests accelerated pathway
For the past decade, Stealth BioTherapeutics has ridden a rollercoaster trying to convince the Food and Drug Administration…
Civica says study ‘validates’ its model for selling low-cost generics
Five years after launching, a unique nonprofit drug company has published data showing that consumers and health plans…
Scientists call for 10-year ban on CRISPR for germline gene editing
Megan Molteni reports on discoveries from the frontiers of genomic medicine, neuroscience, and reproductive tech. She joined STAT…
We’re reading about Trump drug-pricing plan, obesity drug trial data
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating,…
Amid FDA chaos, approval of a rare disease drug gets delayed — again
Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly…
Patients struggle as compounded GLP-1 access rapidly shrinks
The explosion of compounded GLP-1 offerings over the past two years is coming to an end, and many…