source
- STAT+: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and moreSanofi asked the FDA to pull teplizumab out of a speedy review voucher program after a political appointee disagreed with staff over its approvalSTAT · 2mo ago↗ source
- STAT+: FDA revisits a rare cancer treatment it rejected a few months agoSecret drug pricing deals, a virtual AI cancer clinic, and other biotech news from The ReadoutSTAT · 2mo ago↗ source
- Atara, Pierre Fabre's cell therapy to get another shot at FDA approvalThere's new life for a twice-rejected T cell therapy from Atara Biotherapeutics and Pierre Fabre Pharmaceuticals. US regulators are willing to reconsider using a Phase 3 study as the basis for an a…