US Pharma MarketingSobi receives CRL for gout combination drug over manufacturing
The FDA has issued Sobi, also known as Swedish Orphan Biovitrum, a complete response letter for its combination gout treatment over production concerns and issues with its third-party manufacturing sites. 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…
The FDA has issued Sobi, also known as Swedish Orphan Biovitrum, a complete response letter for its combination gout treatment over production concerns and issues with its third-party manufacturing sites.
The agency has requested additional ...
Source: Endpoints News