FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

55 Novel Drugs Approved in 2023: Report

[ Price : $8.95]

The CDER Drug Trials Snapshop Summary Report 2023 provides statistics on the 55 novel drugs the Center approved in 2023.

Juno Therapeutics Breyanzi Approved for Lymphoma

[ Price : $8.95]

FDA grants Juno Therapeutics accelerated approval for its BLA for Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy for ad...

Rep Green Bill on Vaccine Data Transparency

[ Price : $8.95]

Rep. Mark Green (R-TN) introduces the Vaccines in Trial and Liability Act of 2024 that would ensure Americans are protected from f...

CGMP Violations in Grupo Contract Test Lab

[ Price : $8.95]

FDA warns Uruguays Grupo Quimico SRL about CGMP violations in its work as a contract testing laboratory for drug companies.

Day One Bio Granted Pediatric Voucher

[ Price : $8.95]

Federal Register notice: FDA announces that it issued Day One Biopharmaceuticals a priority review voucher for its recently approv...

FDA Clears Qiagens Respiratory Panel Plus

[ Price : $8.95]

FDA clears a Qiagen 510(k) for the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use in diagnosing upper respirato...

FDA Warns Westwood Labs on CGMP Violations

[ Price : $8.95]

FDA warns Azusa, CA-based Woodward Laboratories about CGMP violations in its production of finished drugs.

Pull Yutrepia Tentative Approval: Petition

[ Price : $8.95]

United Therapeutics asks FDA not to approve a Liquidia NDA for Yutrepia because the sole supplier of active pharmaceutical ingredi...

Federal Court Dismisses AcelRx Pharms Suit

[ Price : $8.95]

A California federal court tosses a shareholder class action suit claiming that AcelRx deliberately used marketing materials for i...

Complete Response Letter for 4-Dose Heplisav-B

[ Price : $8.95]

FDA issues a complete response letter for a Dynavax sBLA for a new indication for its Heplisav-B hepatitis vaccine.