FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Statistical Analysis of FDA Warning Letters

[ Price : $8.95]

A Hyman, Phelps & McNamara statistical analysis of FDA Warning Letters published by FDLI shows that nearly three-quarters of Warni...

AstraZeneca Reports Favorable Hypertension Drug Data

[ Price : $8.95]

AstraZeneca says its investigational drug baxdrostat met the primary endpoint in the Phase 3 Bax24 trial in patients with resistan...

Fire CDER, OGD Directors: Members of Congress

[ Price : $8.95]

Thirteen Republican House members call on HHS to lay off the CDER director, Office of Generic Drugs director, and others who were ...

FDA Clears Trial Restart of Recurring Stroke Device

[ Price : $8.95]

FDA clears restart of a pivotal clinical trial evaluating the NobleStitch EL system, a device-free, suture-mediated method for clo...

Boehringers Jascayd OKd for Pulmonary Fibrosis

[ Price : $8.95]

FDA approves a Boehringer Ingelheim NDA for Jascayd (nerandomilast) tablets for treating idiopathic pulmonary fibrosis.

FDA Warns Technological Medical

[ Price : $8.95]

FDA warns West Palm Beach, FL-based Technological Medical Advancement about Quality System violations in its production of two una...

Multiple Creative Essences Violations

[ Price : $8.95]

FDA warns Santa Fe Springs, CA-based Creative Essences about CGMP violations in its production of misbranded unapproved drugs.

FDA Outlines Quicker Path for Lexeo Gene Therapy

[ Price : $8.95]

FDA input offers Lexeo Therapeutics a potential accelerated approval pathway for its investigational gene therapy LX2006.

Former CBER Head Marks Joins Eli Lilly

[ Price : $8.95]

After being forced to resign in April, former CBER director Peter Marks accepts a job at Lilly Research Laboratories overseeing mo...

Clinical Hold Lifted on Neurizon ALS Drug

[ Price : $8.95]

FDA lifts a clinical hold on Neurizon Therapeutics on its lead experimental treatment for amyotrophic lateral sclerosis.