FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Hyalex Ortho Breakthrough Status for Cartilage Repair

[ Price : $8.95]

FDA grants Hyalex Orthopedics a breakthrough device designation for the Hyalex Cartilage System, intended for use in repairing car...

FDA Identifies Need for Better Addressing Drug Shortages

[ Price : $8.95]

FDA says drug shortages remain a significant problem and it has identified two issues that need ongoing work to help address the s...

Appealing a CRL in Court May be Worth It: Attorneys

[ Price : $8.95]

Two Hyman, Phelps & McNamara attorneys say a recent case indicated there may be circumstances in which it is worth challenging in ...

Mercks Keytruda Gets Expanded Label

[ Price : $8.95]

FDA approves an expanded label for Mercks Keytruda (pembrolizumab) as monotherapy for treating certain patients with locally advan...

FDA Mostly Denies Celgene/Abraxis Abraxane Petition

[ Price : $8.95]

FDA denies all but one request in a Celgene/Abraxis 2015 petition involving Abraxane.

FDA Clears UVision 360 Luminelle 360 Bx Sheath

[ Price : $8.95]

FDA clears the UVision 360 Luminelle biopsy sheath for uterine and bladder biopsies.

Siemens New Magnetic Resonance Scanner Cleared

[ Price : $8.95]

FDA clears a Siemens Healthineers 510(k) for the Magnetom Free Max, a new High-V magnetic resonance scanner.

FDA Approves Jazz Rylaze for Cancer Chemo Regimen

[ Price : $8.95]

FDA approves Jazz Pharmaceuticals Rylaze as a part of a chemotherapy regimen for a common childhood cancer.

Vifor Asks FDA Reconsideration of Some Venofer Actions

[ Price : $8.95]

Vifor asks FDA to reconsider its decision to change the established names and active ingredients for iron-containing complex drugs...

FDA Revokes EUAs for Non-NIOSH-Approved Respirators

[ Price : $8.95]

FDA revokes emergency use authorizations for all non-NIOSH-approved disposable respirators and decontamination and bioburden reduc...