Atara, Pierre Fabre will get another shot at FDA approval, a week after Prasad
US regulators are willing to reconsider using a Phase 3 study of tab-cel as the basis for an approval, after previously rejecting the therapy based on that same study. Topic Hubs AI drug discovery: News, analysis and interviews Antibody-drug conjugates: The next wave of targeted cancer drugs Biopharma M&A and dealmaking: Who’s buying and why Biopharma people moves: CEO changes, executive hires, board positions Biotech IPOs: Tracking the market for new public offerings Biotech venture funding: Who’s raising and where the money is going Cell and gene therapy manufacturing: Scaling the next frontier China biotech: Licensing deals and the Biosecure…
There'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 approval, Atara said ...
Source: Endpoints News