FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

AdventaPharma Wants Generic Ozempic Conditions

[ Price : $8.95]

AdventaPharma asks FDA to impose conditions on ANDAs referencing Ozempic to ensure an equivalent pen injector and active pharmaceu...

Bayer NDA Accepted for Next-Gen Contrast Agent

[ Price : $8.95]

FDA accepts Bayers NDA for gadoquatrane, a next-generation gadolinium-based contrast agent for use in magnetic resonance imaging.

Sen. Cassidy Seeks Postponement of Vaccine Panel

[ Price : $8.95]

In the wake of CDC director Susan Monarezs firing, Senate HELP Committee chair Bill Cassidy (R-LA) calls on HHS to postpone a just...

FDA Recommends More Leqembi MRIs

[ Price : $8.95]

FDA says it is requiring a change in labeling for Eisai/Biogens Alzheimers drug Leqembi to call for an earlier MRI monitoring scan...

FDA-483 on IntegraDose Inspection

[ Price : $8.95]

FDA releases the form FDA-483 with six observations from an inspection at the Minneapolis, MN-based IntegraDose Compounding Servic...

Integra Recalls Surgical Applicators Over Sterility Issues

[ Price : $8.95]

Integra LifeSciences recalls (Class 1) its Extended Tip Applicators due to sterility concerns.

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...