FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Panel to Review Glaxo Kidney Disease Anemia Drug

[ Price : $8.95]

Federal Register notice: FDA advisory committee reviews GlaxoSmithKline NDA for daprodustat, indicated for treating anemia due to ...

Azurity's Konvomep Approved for Gastric Ulcers

[ Price : $8.95]

FDA approves an Azurity Pharmaceuticals NDA for Konvomep (omeprazole and sodium bicarbonate for oral suspension), a proton pump in...

Vibrant Gastro Colon Vibrator Gets Authorization

[ Price : $8.95]

FDA grants Vibrant Gastro de novo marketing authorization for its Vibrant, an orally administered drug-free capsule that provides ...

Imfinzi Approved for Biliary Tract Cancer

[ Price : $8.95]

FDA approves an AstraZeneca supplemental BLA for Imfinzi (durvalumab) for combination use with gemcitabine and cisplatin for adult...

AstraZeneca Asthma Drug Goes Before Panel

[ Price : $8.95]

Federal Register notice: FDA announces an 11/8 Pulmonary-Allergy Drugs Advisory Committee meeting to review AstraZeneca NDA for a ...

FDA Observations from 3 Biocon Biologics Inspections

[ Price : $8.95]

FDA issues a form FDA-483 with multiple inspection observations to Indias Biocon Biologics following three inspections at manufact...

Cue Health Seeks De Novo for At-Home Flu Test

[ Price : $8.95]

Cue Health files a de novo marketing submission for its Cue Flu Molecular Test for at-home and point-of-care use.

GDUFA Research Supports Generic Drug Development

[ Price : $8.95]

The FDA FY 2021 GDUFA Science and Research Outcomes Report demonstrates how GDUFA research projects have contributed to the develo...

FDA, C-Path Exploring Lysosomal Diseases Group

[ Price : $8.95]

FDA says it is partnering with the Critical Path Institute to explore creating a Lysosomal Diseases Consortium as part of the Acce...

eCential Robotics Bone Surgical System Cleared

[ Price : $8.95]

FDA clears an eCential Robotics 510(k) for its 3D imaging, navigation and robotics guidance system for use in bone surgical proced...