US Pharma MarketingUnicycive gets second CRL for kidney drug as manufacturing woes continue
Unicycive 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 the IRA: Tracking the government's negotiation power FDA policy and drug approvals: What’s changing…
Unicycive Therapeutics’ chronic kidney disease drug was rejected by the FDA for a second time over persistent issues at a third-party contract manufacturer.
The company’s phosphate binder drug oxylanthanum carbonate (OLC) was being reviewed as ...
Source: Endpoints News