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Otsuka ICU Recalls Mislabeled Potassium Chloride Injection

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Otsuka ICU Medical recalls (Class 1) one lot of its potassium chloride injection, 20 mEq, after discovering that the overwrap labe...

FDA OKs Aqua Medical IDE for Endoscopic Technology Trial

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FDA gives investigative device exemption approval for an Aqua Medical pilot clinical trial of its Proximal Intestinal Mucosal Abla...

Reforms Needed to Boost Efficiency of Global Cancer Trials: Report

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A new report from the Reagan-Udall Foundation calls for broad operational and policy reforms to improve the efficiency, representa...

Lawsuit Against Tidmarsh Paints Troubling Picture

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Aurinia Pharmaceuticals lawsuit against CDER director George Tidmarsh includes screenshots of troubling text messages and emails f...

Top Drug Chief Resigns Amid Misconduct Probe, Lawsuit

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CDER director George Tidmarsh resigns after being placed on administrative leave amid an internal ethics investigation and a defam...

Drug for Ultra-Rare Mitochondrial Disease Approved

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FDA approves UCBs Kygevvi (doxecitine and doxribtimine) for treating thymidine kinase 2 deficiency.

FDA Lifts Hold on Rein Pulmonary Fibrosis Trial

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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...

Inspection of Alvotechs Biosimilar Ends in Rejection

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FDA sends Alvotech a complete response letter on its BLA for AVT05, a biosimilar to Janssen Pharmaceuticals Simponi (golimumab), d...

FDA Shifts Stance on AMT-130 BLA Data

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FDA tells gene therapy company uniQure that the agency may no longer view the companys Phase 1-2 data for its Huntingtons disease ...

FDA to Unveil Faster Pathway for Gene-Editing Therapies

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CBER director Vinay Prasad says FDA is preparing to introduce a new, accelerated pathway for approving custom gene-editing therapi...