FDA tells gene therapy company uniQure that the agency may no longer view the companys Phase 1-2 data for its Huntingtons disease therapy AMT-130 as s...
Aurinia Pharmaceuticals lawsuit against CDER director George Tidmarsh includes screenshots of troubling text messages and emails from Tidmarsh to Kevi...
CDER director George Tidmarsh resigns after being placed on administrative leave amid an internal ethics investigation and a defamation lawsuit tied t...
FDA approves UCBs Kygevvi (doxecitine and doxribtimine) for treating thymidine kinase 2 deficiency.
FDA grants interchangeability designations to Celltrions denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), making them f...
FDA issues an updated safety communication confirming long-term post-approval data showing that the Hintermann Series H3 Total Ankle Replacement syste...
Eli Lilly says its investigational weight-loss pill met most criteria for FDAs new national priority voucher program and could be a potential candidat...
Johnson & Johnson files a supplemental BLA seeking to expand the use of its biologic therapy Stelara (ustekinumab) to treat children aged two years an...
