FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

AI Prostate Cancer Detector Cleared by FDA

[ Price : $8.95]

FDA clears an Ibex Medical Analytics 510(k) for the Ibex Prostate Detect, an in vitro diagnostic that uses artificial intelligence...

Tempest Gets Fast Track for Amezalpat

[ Price : $8.95]

FDA grants Tempest Therapeutics a fast track designation for amezalpat (TPST-1120) for treating patients with hepatocellular carci...

Roche Shares Positive Data on Gazyva

[ Price : $8.95]

Roche shares with FDA positive data from the Phase 3 REGENCY trial of Gazyva (obinutuzumab) in people with active lupus nephritis.

Lawmakers Urge FDA to Block Super Bowl Drug Ad

[ Price : $8.95]

Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) call on FDA to take enforcement action against a planned direct-to-consumer ...

RapidAI Wins Clearance for Lumina 3D

[ Price : $8.95]

FDA clears a RapidAI 510(k) for its Lumina 3D, an automated 3D imaging reconstruction device designed to replace manual workflows.

Adicet Wins Fast Track for Lupus Cell Therapy

[ Price : $8.95]

FDA grants Adicet Bio a fast-track designation for ADI-001 and its use in treating adult patients with refractory systemic lupus e...

FDA Alert on Breast Implant Illness

[ Price : $8.95]

FDA alerts healthcare professionals and patients about medical device reports detailing breast implant illness with systemic sympt...

AbbVie Antibiotic OKd for Abdominal Infections

[ Price : $8.95]

FDA approves an AbbVie NDA for Emblaveo (aztreonam and avibactam), a combination antibiotic for combination use with metronidazole...

Senate Dems Denounce FDA Communication Freeze

[ Price : $8.95]

A group of 24 Senate Democrats write HHS and urge an end to the ongoing and unprecedented freeze on all external communications an...

Alert on Bards Rotarex Atherectomy System

[ Price : $8.95]

FDA issues an alert about Bard Peripheral Vasculars Rotarex Atherectomy Systems due to risks of fracture or breakage.