FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Warns of Serious Liver Risks Linked to Tavneos

[ Price : $8.95]

FDA issues a safety alert warning that patients taking Amgens Tavneos (avacopan) for a rare autoimmune condition may face a risk o...

FDA Seeking Input on Expanding Digital Health Tech in Trials

[ Price : $8.95]

Looking to modernize drug and biologic development, FDA seeks industry and public input on how to expand the use of digital health...

Scholar Rock Refiles BLA for Spinal Muscular Atrophy Therapy

[ Price : $8.95]

Scholar Rock resubmits its BLA for apitegromab, an investigational therapy for children and adults with Spinal Muscular Atrophy.

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.

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...