FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

OpdivoAVD Priority Review for Hodgkin Lymphoma

[ Price : $8.95]

FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) and its use in combination with AVD...

Exceptional Performance of TAP Pilot: Report

[ Price : $8.95]

An independent assessment of the FDA Total Product Lifecycle Advisory Program pilot finds it met its objectives exceptionally well...

FDA OKs 1st At-Home Stimulator for Depression

[ Price : $8.95]

FDA approves the first at-home, prescription-only brain-stimulation device to treat major depressive disorder.

Medical Device Recall Improvement Act Reintroduced

[ Price : $8.95]

Rep. Jan Schakowsky and Sen. Dick Durbin reintroduce their Medical Device Recall Improvement Act to improve medical device recall ...

Serina Files Response on Parkinsons Drug Clinical Hold

[ Price : $8.95]

Serina Therapeutics files a complete response to an FDA clinical hold on SER-252, the companys lead investigational therapy for ad...

FDA Signals Plan to Ease Supplement-Label Disclaimers

[ Price : $8.95]

FDA weighs changes to a long-standing labeling rule for dietary supplements and will temporarily exercise enforcement discretion o...

HCT/P Violations at Ponya Therapeutics

[ Price : $8.95]

FDA warns Brookhaven, GA-based Ponya Therapeutics about violations of regulations governing human cells, tissues, and cellular and...

FDA Clears Rx Digital Therapeutic for Adult ADHD

[ Price : $8.95]

FDA clears a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improve attention in adults with att...

Positive Results for Roche Giredestrant in Some Breast Cancers

[ Price : $8.95]

Roche reports positive Phase 3 lidERA trial results for its giredestrant selective estrogen receptor degrader endocrine therapy in...

FDA Neurological Regulator Joins Musks Neuralink

[ Price : $8.95]

Reuters reports that Daniel McMullen, the former director of the CDRH Office of Neurological and Physical Medicine Devices, has jo...