FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Lifts Hold on Rein Pulmonary Fibrosis Trial

[ Price : $8.95]

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

Lawsuit Against Tidmarsh Paints Troubling Picture

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Inspection of Alvotechs Biosimilar Ends in Rejection

[ Price : $8.95]

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

[ 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 ...

FDA to Unveil Faster Pathway for Gene-Editing Therapies

[ Price : $8.95]

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

FDA Moves to Restrict Unapproved Fluoride Drugs

[ Price : $8.95]

FDA announces new actions aimed at protecting children from unapproved ingestible fluoride prescription drugs.

Interchangeability Status on Celltrion Biosimilars

[ Price : $8.95]

FDA grants interchangeability designations to Celltrions denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-...

Safety Data Update on Hintermann Ankle Device

[ Price : $8.95]

FDA issues an updated safety communication confirming long-term post-approval data showing that the Hintermann Series H3 Total Ank...