FDA returns to releasing pharma rejection letters with 14 new CRLs
FDA posted 14 new rejection letters online after briefly pausing CRL releases due to a pharma-backed citizen petition. Recipients include Jiangsu Hengrui and Elevar Therapeutics, and Ipsen. 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…
The FDA on Friday posted 14 new rejection letters to pharma companies online, days after HHS confirmed to Endpoints News that the agency had paused new CRL releases because of a pharma-backed ...
Source: Endpoints News