FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Repeat CGMP Issues at Miers Laboratories

[ Price : $8.95]

FDA warns New Zealands Miers Laboratories about repeat CGMP violations in its manufacturing of finished drugs.

Neurocrines NMDA Modulator Fails Phase 2 in Depression

[ Price : $8.95]

Neurocrine Biosciences reports that its Phase 2 study of NBI-1070770, an investigational NMDA receptor modulator for major depress...

Complying with QMSR Critical Business Strategy: Attorneys

[ Price : $8.95]

Alston & Bird attorneys urge medical device companies to move quickly to prepare to implement FDAs new Quality Management System R...

enGene Reports 62% Response Rate for Gene Therapy

[ Price : $8.95]

enGene says Phase 2 data showed that its gene therapy detalimogene voraplasmid produced a 62% complete response rate at six months...

CGMP Violations at Taizhou Kangping

[ Price : $8.95]

FDA warns Chinas Taizhou Kangping Medical Science and Technology Co. about CGMP violations in its manufacturing of over-the-counte...

Oncology Guru Pazdur Named New CDER Director

[ Price : $8.95]

FDA names 26-year FDA veteran Richard Pazdur as the new CDER director, replacing George Tidmarsh after he recently stepped down am...

Avenzo Therapeutics Wins Fast Track for Lung Cancer Drug

[ Price : $8.95]

FDA grants Avenzo Therapeutics a fast track designation for AVZO-1418, the companys investigational EGFR/HER3 bispecific antibody-...

FDA Nixes Certain Boxed Warnings from Hormone Therapy

[ Price : $8.95]

FDA says it will begin removing broad boxed warnings from menopause-related hormone replacement therapy products based on a recent...

Roche BTK Inhibitor Sees Positive Phase 3 MS Data

[ Price : $8.95]

Roche says its investigational Brutons tyrosine kinase inhibitor fenebrutinib showed the strongest late-stage results yet reported...

FDA Flags Sterility, Cleaning and Quality at Alvotech Facility

[ Price : $8.95]

FDA cites Alvotechs Reykjavik, Iceland, manufacturing site for widespread sterility assurance, environmental monitoring, and quali...