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FDA lifts a clinical hold against the Rein Therapeutics Phase 2 RENEW trial evaluating LTI-03 in patients with idiopathic pulmonar...[ Price : $8.95]
Aurinia Pharmaceuticals lawsuit against CDER director George Tidmarsh includes screenshots of troubling text messages and emails f...[ Price : $8.95]
CDER director George Tidmarsh resigns after being placed on administrative leave amid an internal ethics investigation and a defam...[ Price : $8.95]
FDA approves UCBs Kygevvi (doxecitine and doxribtimine) for treating thymidine kinase 2 deficiency.[ Price : $8.95]
FDA sends Alvotech a complete response letter on its BLA for AVT05, a biosimilar to Janssen Pharmaceuticals Simponi (golimumab), d...[ Price : $8.95]
FDA tells gene therapy company uniQure that the agency may no longer view the companys Phase 1-2 data for its Huntingtons disease ...[ Price : $8.95]
CBER director Vinay Prasad says FDA is preparing to introduce a new, accelerated pathway for approving custom gene-editing therapi...[ Price : $8.95]
FDA announces new actions aimed at protecting children from unapproved ingestible fluoride prescription drugs.