FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Darmiyan De Novo for Alzheimers Assessor

[ Price : $8.95]

FDA grants Darmiyan a de novo marketing authorization for its clinical test BrainSee for assessing Alzheimers dementia risk.

Fresenius Recalls Infusion Pump

[ Price : $8.95]

Fresenius Kabi recalls its Ivenix Large Volume Pump because some units have mechanical issues with the fluid valve pins in the dev...

Keytruda Approved for FIGO Cervical Cancer

[ Price : $8.95]

FDA approves Mercks Keytruda (pembrolizumab) with chemoradiotherapy (CRT) for treating patients with FIGO 2014 Stage III-IVA cervi...

Bill to Stockpile Pediatric Cancer Drugs

[ Price : $8.95]

Three Democrat U.S. Reps. introduce the Pediatric Cancer Drug Supply Act of 2024, legislation that is intended to ensure there is ...

FDA Needs More Supplement Authority: GAO

[ Price : $8.95]

The Government Accountability Office says its testing of prenatal dietary supplements found that many had more or less nutrients t...

Shorla NDA Accepted for Breast/Ovarian Cancer

[ Price : $8.95]

FDA accepts for review a Shorla Oncology NDA for SH-105 for treating breast and ovarian cancer.

Florida Drug Import Plan Non-Starter: Canada

[ Price : $8.95]

Canadian officials say they will act to prevent Floridas importation of drugs from that country to cause a shortage in Canada.

ICH Viral Safety Evaluation Guidance

[ Price : $8.95]

FDA publishes an ICH guidance on evaluating the viral safety of biotechnology products derived from human or animal cell lines.

No Clarity Yet on Ozempic Suicide Risk: FDA

[ Price : $8.95]

FDA says it has not been able to establish a causal connection between suicidal ideation and drugs like Ozempic and Wegovy and is ...

Stakeholders Take Shots at FDA SIUU Communication Guide

[ Price : $8.95]

Four major stakeholder groups air their disagreement with an FDA revised draft guidance on firms communicating scientific informat...