In another reversal, FDA gives uniQure accelerated approval path for Huntington
The FDA has reversed course and allowed uniQure to seek accelerated approval for the Huntington 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 Act CRISPR and gene editing: The push for in vivo therapies Drug pricing and…
Regulatory flexibility appears to be back on the FDA’s menu following the departures of Marty Makary and Vinay Prasad.
At the center of the debate, once again, is the ...
Source: Endpoints News