SPOTLIGHT: FDA demands delay Genzyme approval


Genzyme has been handed a letter from the FDA spelling out a new set of demands for data on Synvisc-One, a new version of its osteoarthritis drug that is dosed at twice a year. Genzyme says the agency's demands will delay an approval until the second half of next year. Report

Suggested Articles

Pliant Therapeutics will use the proceeds to push its lead program through midstage trials in fibrotic liver and lung diseases.

Cancer biotech Novellus has struck a deal with Plexxikon for its early- to midstage BRAF-inhibiting hopeful PLX8394.

Chinook Therapeutics is set to merge with fallen Big Pharma darling Aduro Biotech to create a kidney disease player with $180 million in cash.