FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Priority Review for Dupixent sBLA

[ Price : $8.95]

FDA accepts for priority review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on main...

Jemperlis Regulatory Review Period Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Jemperli (...

Moderna RSV Vaccine Review Pushed Back

[ Price : $8.95]

FDA tells Moderna that it needs a couple more weeks to complete the review of its BLA for mRNA-1345, the companys investigational ...

Megadyne Removing Mega Soft Electrodes

[ Price : $8.95]

Megadyne recalls and removes from the market all Mega Soft Pediatric Patient Return Electrodes after receiving reports of patient ...

SN Bioscience Gets Fast Track for Lung Cancer

[ Price : $8.95]

FDA gives SN Bioscience a fast-track designation for its nanoparticle anticancer drug SNB-101 for treating small cell lung cancer.

Route 92 Medical Recalls Faulty Catheters

[ Price : $8.95]

Route 92 Medical recalls (Class 1) several lots of its products containing the Tenzing 7 Delivery Catheters due to multiple instan...

Breakthrough for Novartis Scemblix in Leukemia

[ Price : $8.95]

FDA grants Novartis a breakthrough therapy designation for Scemblix (asciminib) for treating adult patients with newly diagnosed P...

FDA Defines Device Remanufacturing

[ Price : $8.95]

FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing and servicing.

FDA Leaders Financial Ties to Drug Industry Probed

[ Price : $8.95]

A BMJ investigation looks at the relationship between several FDA commissioners and the companies the agency regulates.

Exocel Bio Selling Unapproved Exosomes: FDA

[ Price : $8.95]

FDA says Exocel Bio in San Diego is marketing unapproved exosome products.