FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

4 CGMP Issues at Integrity Partners Facility

[ Price : $8.95]

FDA warns Integrity Partners St. Louis, MO-based Chemisphere drug manufacturing facility about CGMP issues in its production of fi...

Valneva Withdraws BLA for Chikungunya Vaccine

[ Price : $8.95]

Valneva says it has voluntarily withdrawn its BLA for Ixchiq, the companys chikungunya vaccine, based on FDA safety-related restri...

Celcuity NDA Gets Priority Review for Breast Cancer

[ Price : $8.95]

FDA accepts for priority review a Celcuity NDA for gedatolisib in patients with hormone receptorpositive, HER2-negative, PIK3CA wi...

Moderna/Merck Report Positive Data on Melanoma Vaccine

[ Price : $8.95]

Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran a...

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.

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 ...