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 lifts a clinical hold against the Rein Therapeutics Phase 2 RENEW trial evaluating LTI-03 in patients with idiopathic pulmonary fibrosis.
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.
