FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Notice on Pathogen Reduction Workshop Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a 9/17 notice announcing an 11/29 public workshop entitled Pathogen Reduction Technologies f...

Grifols Test OKd for Blood Group Genotyping

[ Price : $8.95]

FDA approves Grifols ID Core XT molecular diagnostic test for blood group genotyping.

BMS Opdivo Trial Misses Primary Endpoint in Lung Cancer

[ Price : $8.95]

Bristol-Myers Squibb reports disappointing topline results from its Phase 3 CheckMate-331 study evaluating Opdivo (nivolumab) vers...

FibriCheck Smartphone App Cleared for Heart Rhythm

[ Price : $8.95]

FDA clears a FibriCheck 510(k) for its smartphone application that monitors heart rhythm disorders by using an optical signal orig...

Sutro Biopharma Orphan Status for Multiple Myeloma Therapy

[ Price : $8.95]

FDA grants Sutro Biopharma an orphan drug designation for STRO-001 for treating multiple myeloma.

Panel Gives Mixed Vote on Trevena Pain Drug

[ Price : $8.95]

FDAs Anesthetic and Analgesic Drug Products Advisory Committee votes 8 to 7 to recommend not approving Trevenas next-generation op...

Require High-Quality Device Evidence: Blog

[ Price : $8.95]

Cardiologist Rita Redberg says in a Health Affairs online post that FDA should require high-quality evidence for approval of medic...

Generic Drug Approvals Set New Record

[ Price : $8.95]

The CDER Office of Generic Drugs sets a new record for generic drug approvals.

TransEnterix Gains Clearance for Smaller Surgery Instruments

[ Price : $8.95]

FDA clears a TransEnterix 510(k) clearance for 3 millimeter diameter instruments for its Senhance System for use in microlaparosco...

Boehringer sNDA for Broader Stiolto Respimat Label OKd

[ Price : $8.95]

FDA approves a Boehringer Ingelheim supplemental NDA for new labeling on its Stiolto Respimat (tiotropium bromide and olodaterol) ...