FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Clears SimBioSys TumorSight Expanded Use

[ Price : $8.95]

FDA clears a SimBioSys 510(k) for TumorSight Viz to expand its use by breast surgeons through artificial intelligence-based image ...

Merus Zeno BLA Gets 3 Month Review Extension

[ Price : $8.95]

FDA extends by three months its priority review of a Merus BLA for Zeno (zenocutuzumab) for treating patients with certain types o...

Support, Suggestions for FDA Rare Disease Hub

[ Price : $8.95]

Four rare disease stakeholders say they support an FDA plan to create a Rare Disease Innovation Hub and suggest its initial priori...

Lawyer Says Not Enough FDA Digital Health Standards

[ Price : $8.95]

Attorney Bradley Thompson says he is surprised and disappointed that FDA is not approving enough new consensus standards to suppor...

Pilot Evaluating Quicker Reviews for Some Drugs

[ Price : $8.95]

FDA announces a pilot program designed to expedite the review of new therapies addressing unmet medical needs.

Clinical Holds Lifted on 3 CARsgen Cell Products

[ Price : $8.95]

FDA removes the clinical holds on three CARsgen Therapeutics clinical trials evaluating CT053, CT041, and CT071.

Phase 3 Study on Disc Medicines Bitopertin

[ Price : $8.95]

FDA agrees on a Phase 3 study design for Disc Medicines bitopertin and its use in treating a rare sunlight sensitivity disorder.

Quanta Dialysis Home Dialysis Device Cleared

[ Price : $8.95]

FDA clears a Quanta Dialysis Technologies 510(k) for the use of its Quanta Dialysis System in the home setting.

Mark Cubans Generic Operation Hit with 483

[ Price : $8.95]

Mark Cubans Cost-Plus Manufacturing and Compounding facility in Dallas, TX, receives a Form FDA-483 based on findings from a recen...

Ionis NDA for Hereditary Angioedema Attacks

[ Price : $8.95]

FDA accepts for review an Ionis Pharmaceuticals NDA for donidalorsen, an RNA-targeted treatment for preventing hereditary angioede...