FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

pCR May Not be Valid Rectal Cancer Endpoint: Study

[ Price : $8.95]

A Tulane University researcher says FDAs use of pathologic complete response as a surrogate endpoint for rectal cancer treatments ...

FDA Looking to Expand Project Orbis Outside Oncology

[ Price : $8.95]

FDA Oncology Center of Excellence director Richard Pazdur says the agency and its international partners are considering expanding...

FDA AI Moves Raise Questions: Attorneys

[ Price : $8.95]

Three Akin attorneys say regulated industry continues to have questions about FDA actions in launching an internal artificial inte...

Panel Votes Down GSK Multiple Myeloma Drug

[ Price : $8.95]

FDAs Oncologic Drugs Advisory Committee votes against approving GSKs BLA for Blenrep (belantamab mafodotin) for treating adults wi...

Dexcom Recalls Dexcom Glucose Monitor Receivers

[ Price : $8.95]

Dexcom recalls certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because a speaker problem may prevent an alert fr...

Investigate GLP-1 Online Marketing: Blackburn

[ Price : $8.95]

Sen. Marsha Blackburn and Tennessee attorney general Jonathan Skrmetti call on the Federal Trade Commission to open an investigati...

Caranx AI Valve Replacement Software Cleared

[ Price : $8.95]

FDA clears a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operativ...

Sandoz Recalls Mislabeled Cefazolin for Injection

[ Price : $8.95]

Sandoz expands a 6/25 recall of cefazolin for injection to include one additional lot after the company received a customer compla...

FDA Warns Firm Marketing Blood Pressure Estimator

[ Price : $8.95]

FDA warns Boston, MA-based Whoop that it is illegally marketing an unapproved medical device that estimates blood pressure, despit...

Anselamimab Trial Misses Primary Endpoint in Amyloidosis

[ Price : $8.95]

A Phase 3 clinical trial evaluating Alexions anselamimab for light chain amyloidosis fails to meet its primary endpoint, but shows...