FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Pledges Prompt CRL Release

[ Price : $8.95]

FDA releases 89 previously unpublished complete response letters and says future letters will be released immediately after transm...

Medtronic Recalls DLP Left Heart Vent Catheters

[ Price : $8.95]

Medtronic Perfusion Systems recalls (Class 1) its DLP Left Heart Vent Catheters (malleable body and vented connector) because the ...

FDA Posts Alopecia Complex Case Study

[ Price : $8.95]

FDA posts a drug complex innovative design case study for a higher dose of an alopecia areata drug that did not assign participant...

Pyrukynd sNDA Extended Due to REMS Review

[ Price : $8.95]

FDA extends by three months its review of Agios Pharmaceuticals supplemental NDA seeking to expand the use of Pyrukynd (mitapivat)...

FDA Says Lillys Olomorasib is Breakthrough Therapy

[ Price : $8.95]

FDA grants breakthrough therapy designation to Lillys oloromasib for certain lung cancers.

14 GenoGenix Inspection Observations

[ Price : $8.95]

FDA releases the form FDA-483 containing 14 observations from an inspection at the GenoGenix outsourcing facility in Boca Raton, F...

Sanofi Dermatitis Drug Meets Endpoints in Study

[ Price : $8.95]

Sanofi says its investigational antibody amlitelimab met all primary and key secondary endpoints in a late-stage trial of patients...

RFK Jr. Grilled at Heated Senate Hearing

[ Price : $8.95]

Bipartisan criticism of Health and Human Services secretary Robert F. Kennedy Jr. dominates a contentious three-hour Senate Financ...

Prasad Has Covid YouTube Videos Pulled

[ Price : $8.95]

The Guardian says CBER director Vinay Prasad successfully had videos of him criticizing Covid vaccines removed from the YouTube ch...

Boehringer Gets Breakthrough Status for Hernexeos

[ Price : $8.95]

FDA grants Boehringer Ingelheim a breakthrough therapy designation for Hernexeos (zongertinib) tablets for the first-line treatmen...