FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Mercks Oral PCSK9 Candidate Cuts LDL Cholesterol in Late-Stage Trial

[ Price : $8.95]

Merck says new Phase 3 data show its investigational cholesterol drug enlicitide significantly lowered bad cholesterol compared wi...

Novel CAR-T Therapy Gets Breakthrough Status

[ Price : $8.95]

A novel off-the-shelf CAR-T cell therapy developed by researchers at Washington University School of Medicine in St. Louis receive...

FDA Pharma Disclosures Raise Transparency-Confidentiality Tensions

[ Price : $8.95]

FDA's more aggressive approach to publicizing its criticisms of drugmakers draws both praise from investors and concern across the...

FDA Records Reveal Lapses in Drug Safety Checks: Analysis

[ Price : $8.95]

FDA inspection records show that some generic drug manufacturers are routinely failing to carry out basic safety and quality check...

FDA Crackdown on CAR-T Promotion in Coordinated Action

[ Price : $8.95]

In a coordinated action, CBER issues four untitled letters targeting promotional materials for leading T-cell therapies and signal...

Praxis Relutrigine NDA Accepted for Rare Pediatric Epilepsies

[ Price : $8.95]

FDA accepts for priority review a Praxis Precision Medicines NDA for relutrigine, an investigational therapy targeting rare geneti...

FDA OKs Higher Dose Regimen for Spinraza

[ Price : $8.95]

FDA approves a higher-dose regimen of Biogens Spinraza (nusinersen) for treating spinal muscular atrophy.

Editorial Criticizes Makary Over Leadership Decisions

[ Price : $8.95]

The Washington Times publishes an opinion piece that draws attention to growing criticism of FDA commissioner Marty Makary.

Medtronic Wins Expanded Clearance for AXiS System

[ Price : $8.95]

Medtronic wins 510(k) clearance for its Stealth AXiS surgical system in cranial and ear, nose and throat procedures.

FDA Guide on Patient Preferences in Device Submissions

[ Price : $8.95]

FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycl...