FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Diabetes Device Smartphone Alerts Malfunctioning: FDA

[ Price : $8.95]

An FDA safety alert on certain diabetes devices that rely on a smartphone to deliver critical safety alerts warns that these may m...

More States Want to Import Drugs: Bloomberg

[ Price : $8.95]

A Bloomberg Law report says New York is the latest state to indicate an interest in the FDA pathway to import lower-cost drugs fro...

Ziftomenib NDA Due in 2nd Quarter: Kura/Kyowa

[ Price : $8.95]

Kura Oncology and Kyowa Kurin say they expect to submit a ziftomenib NDA to FDA in the second quarter of 2025.

Breakthrough Status for ACR-368 OncoSignature Assay

[ Price : $8.95]

FDA grants Acrivon Therapeutics a breakthrough device designation for the ACR-368 OncoSignature assay, a multiplex immunofluoresce...

Baxter Recalls Life2000 Ventilators

[ Price : $8.95]

Baxter Healthcare Corporation recalls its Life2000 Ventilator System due to a nonconforming battery charger.

Monlunabant Trial Misses End Point in Kidney Trial

[ Price : $8.95]

Novo Nordisk says a recent Phase 2 trial of monlunabant in diabetic kidney disease patients failed to meet its primary endpoint.

CGMP Violations in Imperial Palace Records

[ Price : $8.95]

FDA warns Chinas Imperial Palace Commodity about CGMP violations in its manufacturing of over-the-counter drugs.

BioStem Illegally Marketing Cellular Products: FDA

[ Price : $8.95]

FDA warns Pompano Beach, FL-based BioStem Life Sciences that it is illegally marketing cellular products that also reflect CGMP vi...

Global Calcium CGMP Deviations

[ Price : $8.95]

FDA warns Indias Global Calcium about CGMP deviations in its manufacture of active pharmaceutical ingredients.

Susvimo OKd for Diabetic Macular Edema

[ Price : $8.95]

FDA approves a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema.