FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Seeks Industry Data for Kidney Biomarker Initiative

[ Price : $8.95]

FDA launches a new effort to aggregate clinical trial data on kidney safety biomarkers, seeking pharmaceutical industry participat...

Alert on GE HealthCare Infant Resuscitation Systems

[ Price : $8.95]

FDA issues an early alert warning healthcare providers about a potentially high-risk defect affecting certain infant resuscitation...

PhRMA Urges FDA to Clarify Digital Health Technology Standards

[ Price : $8.95]

PhRMA calls on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, argu...

FDA Expands Pfizer Bleeding Drug Approval

[ Price : $8.95]

FDA approves an expanded indication for Pfizer's hemophilia treatment Hympavzi (marstacimab-hncq), allowing its use in additional ...

Stakeholders Press FDA to Pause Voucher Program Amid Transparency Concerns

[ Price : $8.95]

Stakeholders at FDA's public hearing on the Commissioners National Priority Voucher program urge the agency to temporarily suspend...

House Passes $7.1 Billion FDA Spending Bill

[ Price : $8.95]

The House passes FDAs appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency.

FDA Rejects Xspray Pharma's Nilopki Application

[ Price : $8.95]

FDA issues Xspray Pharma a complete response letter for the company's NDA for Nilopki, an improved formulation of nilotinib design...

FDA Breakthrough Device Designations Top 1,280

[ Price : $8.95]

FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlighting the growing use of the e...

FDA Approves Lupin's Interchangeable Lucentis Biosimilar

[ Price : $8.95]

FDA approves a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucen...

Guidance Details Post-Approval Responsibilities for Generics

[ Price : $8.95]

FDA releases a draft guidance outlining post-approval responsibilities facing manufacturers of generic drugs, highlighting require...