FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Early Alert on Abiomed Impella RP Heart Pumps

[ Price : $8.95]

FDA issues an early alert to warn clinicians about a potentially high-risk issue affecting certain Abiomed heart pump devices used...

FDA Officials Personal Legal Actions Trigger Ethics Probe

[ Price : $8.95]

HHS Office of Inspector General begins an ethics investigation into FDA deputy chief of staff Samuel Doran and whether he misled t...

Datroway sBLA for Triple-Negative Breast Cancer Under Review

[ Price : $8.95]

FDA grants AstraZeneca and Daiichi Sankyo a priority review for their antibodydrug conjugate Datroway (datopotamab deruxtecan) as ...

Floridas FDA-Authorized Canadian Drug Import Program Stalls

[ Price : $8.95]

Floridas FDA-authorized drug importation program stalls and has yet to deliver any imported medicines more than two years after re...

Warning Letter Sent to Beta Bionics

[ Price : $8.95]

FDA issues Beta Bionics a Warning Letter following an inspection of the companys Irvine, CA, facility conducted 6/2025.

Aquestives Epinephrine Film Gets Complete Response

[ Price : $8.95]

FDA sends Aquestive Therapeutics a complete response letter for its NDA for Anaphylm, a sublingual epinephrine film for treating T...

FDA Launches PreCheck Drug Manufacturing Pilot

[ Price : $8.95]

FDA launches its new PreCheck pilot program aimed at strengthening domestic pharmaceutical manufacturing by providing earlier regu...

Citizen Petition Seeks Database for Medical Device Labels

[ Price : $8.95]

A patient safety advocacy group files a citizen petition urging FDA to create a comprehensive public database of medical device la...

$17.9 Million Settlement in Generic Drug Price-Fixing Case

[ Price : $8.95]

New York Attorney General Letitia James and a bipartisan coalition of 47 other attorneys general secure $17.85 million from drug m...

FDA Accepts Exelixis NDA for Metastatic Colorectal Cancer

[ Price : $8.95]

FDA accepts for review an Exelixis NDA for zanzalintinib in combination with the immune checkpoint inhibitor atezolizumab for pati...