FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

High Court Agrees to Hear Skinny Label Dispute

[ Price : $8.95]

The U.S. Supreme Court agrees to hear a patent-infringement dispute between generic drugmaker Hikma Pharmaceuticals USA, Inc. and ...

Qualgen FDA 483 Cites Quality Issues

[ Price : $8.95]

FDA inspectors cite Oklahoma-based outsourcing facility Qualgen for a wide range of manufacturing and quality control failures dur...

Alert Issued on Vantives Prismaflex Systems

[ Price : $8.95]

FDA alerts healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after...

Clinical Hold Lifted on GH Research Antidepressant

[ Price : $8.95]

FDA lifts a clinical hold against GH Researchs investigational antidepressant GH001, clearing the way for patient enrollment in th...

Pazdur, Others Concerned About Voucher Program Integrity

[ Price : $8.95]

Former FDA oncology drug leader Richard Pazdur says concerns surrounding a controversial fast-track drug review initiative under c...

Novartis Wins Breakthrough Status for Ianalumab

[ Price : $8.95]

FDA grants Novartis a breakthrough therapy designation to its experimental antibody ianalumab for treating Sjogrens disease.

Teclistamab Cuts Myeloma Risk of Progression by 71%: J&J

[ Price : $8.95]

Johnson & Johnson reports positive results from a late-stage clinical trial showing that its bispecific antibody therapy Tecvayli ...

Scholar Rock Plans BLA Resubmission for Apitegromab

[ Price : $8.95]

Scholar Rock plans to resubmit its BLA seeking approval of apitegromab, a first-in-class muscle-targeted therapy for spinal muscul...

IND Review Procedures SOPP

[ Price : $8.95]

CBER publishes a Standard Operating Policy and Procedure on IND administrative processing and review management procedures.

Compounder Says Lilly, Novo Nordisk Violate Antitrust

[ Price : $8.95]

Strive Specialties, a compounding pharmacy, says in a suit filed in a Texas federal court that Eli Lilly and Novo Nordisk are viol...