FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Tandem Diabetes Insulin Pump App Recall

[ Price : $8.95]

Tandem Diabetes Care updates its March recall of its Apple iOS t:connect mobile app in the U.S. due to an issue that can cause rap...

Creating Hope Reauthorization Act Introduced

[ Price : $8.95]

Sen Susan Collins and a bipartisan group of her colleagues introduce the Creating Hope Reauthorization Act to extend until 2030 th...

Change Biological Drug Monographs: Petition

[ Price : $8.95]

A University of Illinois Chicago College of Pharmacy petition calls on FDA to authorize a new form of monograph for biological pro...

Advisors Surveyed on Committee Reforms

[ Price : $8.95]

3D Communications shares the results from its survey of FDA advisory committee members on committee reform issues.

Surgical Plannings New HipInsight Cleared

[ Price : $8.95]

FDA clears a Surgical Planning Associates 510(k) for its new HipInsight 2.0 mixed-reality guidance system for hip arthroplasty.

Clinical Hold Removed on Dravet Syndrome Drug

[ Price : $8.95]

FDA removes a partial clinical hold on Stoke Therapeutics zorevunersen (STK-001) and its use in children and adolescents with Drav...

FDA Clears BioVie for Parkinsons Trial

[ Price : $8.95]

FDA gives BioVie the go-ahead to begin its Phase 2 SUNRISE-PD trial in Parkinsons disease patients.

Abiomed Recalls Impella CP Heart Pumps

[ Price : $8.95]

Abiomed recalls (Class 1) certain Impella CP with SmartAssist heart pumps after nine devices in a single lot failed inspection.

Kyverna Gets FDA Regenerative Medicine Status

[ Price : $8.95]

FDA awards Kyverna Therapeutics a regenerative medicine advanced therapy designation for the companys CAR T-cell product candidate...

Panel to Discuss Ocaliva Confirmatory Data

[ Price : $8.95]

Federal Register notice: FDA announces a 9/13 advisory committee meeting to discuss an Intercept Pharmaceuticals supplemental NDA ...