Genzyme's Pompe disease treatment Myozyme (alglucosidase alfa) has a revised user fee date of April 28 following FDA's 90-day extension. The extension is to provide time to review additional agency-requested information, Genzyme says. The company submitted the BLA July 28 (1Pharmaceutical Approvals Monthly August 2005, In Brief); the enzyme replacement therapy is receiving a priority review...

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials.