FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Reps Urge FDA Relief on Compounded Hormones

[ Price : $8.95]

Twenty-five bipartisan House representatives urge FDA to create patient-centered policies on compounded hormones that maintain pat...

Guide on LDTs Used With Cancer Drugs

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Oncology Drug Products Used with Certain In Vitro Diagnosti...

Former Tellus Researcher Diaz Debarred

[ Price : $8.95]

Federal Register notice: FDA permanently debars Daylen Diaz from providing services in any capacity to a person that has an approv...

Add Plant-Based Diet Notice to Some Agonists: Petition

[ Price : $8.95]

The Physicians Committee for Responsible Medicine asks FDA to require a notice on all glucagon-like peptide-1 receptor agonists th...

Objectionable Conditions at Chicago Cornea

[ Price : $8.95]

FDA warns Highland, IL-based Chicago Cornea Consultants about violations in its conduct of two clinical studies with investigation...

Bluebird Sickle Cell Gene Therapy BLA Accepted

[ Price : $8.95]

FDA accepts for priority review a bluebird bio BLA for lovotibeglogene autotemcel (lovo-cel), a gene therapy for certain patients ...

AZ Halts Elarekibep Asthma Phase 2a Trial

[ Price : $8.95]

Pieris Pharmaceuticals says its partner AstraZeneca is discontinuing a Phase 2a study of the asthma drug elarekibep.

Complete Response Letter for Aldeyra ADX-2191

[ Price : $8.95]

An FDA complete response letter for Aldeyras ADX-2191 cites a lack of substantial evidence of effectiveness due to a lack of clini...

Anumana Gets Breakthrough on ECG-AI Algorithm

[ Price : $8.95]

FDA grants Anumana a breakthrough device designation for its ECG-AI algorithm for detecting cardiac amyloidosis.

ChatGPT Companies Want Regulation: Califf

[ Price : $8.95]

FDA commissioner Robert Califf says the agency needs to get in front of regulating large language models using ChatGPT that could ...