FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Accepts NDA for Smoking Cessation Drug

[ Price : $8.95]

FDA accepts for review an Achieve Life Sciences NDA for cytisinicline, an investigational treatment for helping those seeking to q...

AI Can Cut Drug Development Costs, Time: Experts

[ Price : $8.95]

Reuters reports that drug manufacturers are turning to artificial intelligence to reduce animal testing and cut costs and time in ...

CGMP Issues at Compounders International

[ Price : $8.95]

FDA warns Castle Rock, CO-based Compounders International Analytical Laboratory about CGMP violations and deviations in its work t...

FDA Publishes OTC Drug Monograph Forecast

[ Price : $8.95]

FDA publishes the 2025 OTC drug monograph forecast showing eight items it expects to address over the next three years.

Shanghai Henlius Prolia and Xgeva Biosimilars OKd

[ Price : $8.95]

FDA approves two new denosumab biosimilars from Shanghai Henlius Biotech and Organon for treating osteoporosis and cancer-related ...

Merck PCSK9 Inhibitor Meets Trial Goals

[ Price : $8.95]

Merck says its oral PCSK9 inhibitor met all primary and secondary endpoints in the CORALreef Lipids Phase 3 trial.

4 Observations in AnazaoHealth Inspection

[ Price : $8.95]

FDA releases the form FDA-483 with four observations from an inspection at the Las Vegas, NV-based AnazaoHealth compounding facili...

FDAs Political Turn Risks Its Core Mission: Expert

[ Price : $8.95]

FDA policy and regulatory expert Steven Grossman warns that the agencys current trajectory risks undermining its effectiveness by ...

Wisconsin Pharmacal CGMP Violations

[ Price : $8.95]

FDA warns Jackson, WI-based Wisconsin Pharmacal about CGMP violations in its production of finished drugs.

FDA Waives Efficacy Studies for Stelara Biosimilar

[ Price : $8.95]

FDA agrees to accept a biosimilar application to compete with Johnson & Johnsons Stelara that does not include clinical efficacy s...