FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Fast Track for Elevations Seribantumab

[ Price : $8.95]

FDA grants fast track designation for Elevation Oncologys seribantumab for the tumor-agnostic treatment of advanced solid tumors t...

inHeart 3D Cardiac Ablation Planning Software Cleared

[ Price : $8.95]

FDA clears an inHeart 510(k) for its inHeart Models software suite that enables 3D visualization and analysis of anatomical struct...

FDA OKs Tibsovo Expanded Use in Leukemia

[ Price : $8.95]

FDA approves a Servier supplemental NDA for Tibsovo (ivosidenib tablets) in combination with azacitidine for treating newly diagno...

2 Zydelig Lymphoma Indications Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws 2 Zydelig lymphoma indications that received accelerated approval because the firm failed t...

CRL for Verrica Molluscum Drug

[ Price : $8.95]

FDA issues a complete response letter to Verrica for its VP-102 dermatology NDA.

FDA Irresponsible in NIPT Safety Warning: Attorneys

[ Price : $8.95]

Three Hyman Phelps attorneys question as irresponsible FDAs decision to issue a safety communication about non-invasive prenatal t...

Former Doctor, Sales Rep Guilty in Fraud Case

[ Price : $8.95]

The Justice Department says a federal jury returned guilty verdicts for a former Florida pain doctor and a former Insys sales repr...

FDA De Novo for Angle Liquid Biopsy Device

[ Price : $8.95]

FDA grants a de novo authorization to Angle plc for its Parsortix system for use in harvesting cancer cells from metastatic breast...

Value Seen in Joint GCP Inspections

[ Price : $8.95]

FDA says research indicates that collaborative good clinical practice inspections by FDA and the European Medicines Agency provide...

BLOCKING Act Would Hurt Generic Drug Access: Attorneys

[ Price : $8.95]

Two former FDA attorneys say proposed BLOCKING legislation will not have its intended effect of accelerating generic drug entry in...