FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Looking at MASH Surrogate

[ Price : $8.95]

FDA says it has accepted an Echosens Letter of Intent to develop Liver Stiffness Measurement by Vibration-Controlled Transient Ela...

Grace Therapeutics NDA for Hemorrhage Drug Submitted

[ Price : $8.95]

FDA accepts for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subar...

Amylyx Nixes AMX0035 Development After Failed Study

[ Price : $8.95]

Amylyx Pharmaceuticals discontinues development of its investigational therapy AMX0035 (sodium phenylbutyrate and taurursodiol) in...

FDA Alert on Abiomed Impella Controllers

[ Price : $8.95]

FDA issues an alert after becoming aware that Abiomed sent a letter to customers recommending that certain automated Impella contr...

BioXcel Plans sNDA for At-Home Bipolar Drug

[ Price : $8.95]

BioXcel Therapeutics plans an early 2026 supplemental NDA submission to expand the label of its agitation treatment Igalmi (BXCL50...

Innate Healthcare Illegally Marketing Stem Cells: FDA

[ Price : $8.95]

FDA warns Scottsdale, AZ-based Innate Healthcare Institute that it is illegally marketing adulterated and misbranded stem cell pro...

Violations in Uscom Spirometer Inspection

[ Price : $8.95]

FDA warns Uscom Kft about Quality System violations in its illegal manufacturing and marketing of adulterated spirometers at its f...

11 QS, MDR Violations at Miach Orthopaedics

[ Price : $8.95]

FDA warns Westborough, MA-based Miach Orthopaedics about eight Quality System and three Medical Device Reporting violations in its...

BIO September Congressional Priorities

[ Price : $8.95]

The Biotechnology Innovation Organization says its congressional lobbying priorities for September are reauthorization of the FDA ...

Multiple GLP Violations at Chinas Jiangsu Kerbio

[ Price : $8.95]

FDA warns Chinas Jiangsu Kerbio Technology Group Co. about its violations of good laboratory practice regulations for nonclinical ...