FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Highlights Expedited Pathways in Drug Approval Report

[ Price : $8.95]

FDAs annual report on drug approvals says the majority of novel drugs approved in 2025 moved through accelerated regulatory pathwa...

Advocacy Groups Press Congress on Biosimilar Legislation

[ Price : $8.95]

Advocacy groups urge Congress to advance legislation that would eliminate the statutory distinction between biosimilars and so-cal...

Sanofi Reports Positive Data for Atopic Dermatitis Drug

[ Price : $8.95]

Sanofi says its experimental antibody amlitelimab showed consistent efficacy and a favorable safety profile across multiple late-s...

FDA OKs Guardant360 CDx Companion Diagnostic

[ Price : $8.95]

FDA approves Guardant Healths Guardant360 CDx liquid biopsy as a companion diagnostic to identify patients with BRAF V600Emutant m...

FDA Drug Ad Enforcement Letters Hit 25-Year High

[ Price : $8.95]

Six King & Spalding attorneys analyze FDA advertising and promotion enforcement letters for drugs and medical devices issued in 20...

Corcept Reports Promising Survival Data for Ovarian Cancer Drug

[ Price : $8.95]

As its NDA is currently under FDA review, Corcept Therapeutics says its experimental drug relacorilant met the overall survival pr...

Alert on Compromised Wound/Burn Dressings

[ Price : $8.95]

FDA issues an early alert warning of a potentially high-risk issue involving certain wound and burn dressings made by Integra Life...

Orphan Status for Experimental Myelofibrosis Therapy

[ Price : $8.95]

FDA grants Opna Bio an orphan drug designation for its investigational treatment OPN-2853 (zavabresib) for treating myelofibrosis.

Drug Shortage Announcements Can Lead to Protective Purchasing: USP

[ Price : $8.95]

A United States Pharmacopoeia study finds that protective purchasing following information on drug shortages can adversely affect ...

6 Observations in Lupin Nagpur Inspection

[ Price : $8.95]

FDA releases the form FDA-483 with six observations from an inspection at the Lupin sterile manufacturing facility in Nagpur, Indi...