FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Caranx Medical PMA for TAVIpilot AI Software

[ Price : $8.95]

Caranx Medical files a PMA for its TAVIpilot AI Software for real-time intra-operative guidance of transcatheter heart valve impla...

ALX Oncology Seeking Accelerated OK for Evorpacept

[ Price : $8.95]

ALX Oncology plans to discuss with FDA its path for seeking accelerated approval for CD47-blocker evorpacept based on positive upd...

FDA Approves Medexus Leukemia NDA

[ Price : $8.95]

FDA approves a Medexus NDA for Grafapex (treosulfan) for use with fludarabine as a preparative regimen for allogeneic hematopoiet...

FDA Delays Non-Rx Drug Final Rule

[ Price : $8.95]

Responding to a Trump Administration order, FDA delays the effective date until 3/21 of a recent final rule entitled Nonprescripti...

CDRHs Sara Brenner Elevated to Acting Commissioner

[ Price : $8.95]

HHS elevates CDRH chief medical officer for in vitro diagnostics Sara Brenner to FDA acting commissioner under the Trump Administr...

Keytruda+Lenvima Mixed Data in Gastroesophageal Cancer

[ Price : $8.95]

Merck and Eisai say results from the Phase 3 LEAP-015 trial evaluating Keytruda plus Lenvima in gastroesophageal adenocarcinoma pa...

FDA Will Review Biogen Spinraza sNDA

[ Price : $8.95]

FDA will review a Biogen sNDA for a Spinraza higher dose regimen.

FDA Removes Diversity Docs From Web Site

[ Price : $8.95]

FDA removes information and documents regarding several diversity-related initiatives and policies, presumably in response to a Tr...

Former FDA Womens Health Head Wood Dies

[ Price : $8.95]

Former FDA associate commissioner for womens health Susan Wood passes away at her home in London after battling glioblastoma (brai...

FDA Extends Review of Stealth Bio NDA

[ Price : $8.95]

FDA extends its review of a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeutic for t...