FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Can Industry Accept a Dysfunctional FDA?: Axios

[ Price : $8.95]

An Axios report following the resignation of CDER director George Tidmarsh questions how much more agency dysfunction industry can...

Sarepta Completes Confirmatory Duchenne Trial

[ Price : $8.95]

Sarepta Therapeutics reports mixed data from its Phase 3 ESSENCE confirmatory study evaluating its Duchenne muscular dystrophy dru...

Compass Pathways Speeds COMP360 Launch

[ Price : $8.95]

Compass Pathways says it expects to be able to launch its COMP360 psilocybin treatment for treatment-resistant depression nine to ...

Otsuka ICU Recalls Mislabeled Potassium Chloride Injection

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ 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.

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...