FDA sends Alvotech a complete response letter on its BLA for AVT05, a biosimilar to Janssen Pharmaceuticals Simponi (golimumab), due to deficiencies i...
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...
CBER director Vinay Prasad says FDA is preparing to introduce a new, accelerated pathway for approving custom gene-editing therapies, aimed at treatin...
FDA announces new actions aimed at protecting children from unapproved ingestible fluoride prescription drugs.
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...
