FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

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...

Limited Covid Vaccines OKd for Upcoming Season

[ Price : $8.95]

FDA approves supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines that target the LP.8.1 variant of...

Regeneron to Seek FDA OK for Myasthenia Gravis Drug

[ Price : $8.95]

Regeneron Pharmaceuticals releases favorable Phase 3 data for its RNA-based therapy cemdisiran and says it will seek FDA approval ...

Lilly Plans NDA for Obesity Pill; Positive Data Released

[ Price : $8.95]

Eli Lilly plans to seek approval for its investigational obesity pill orforglipron following positive topline results from the Pha...

QS Violations at LeMaitre Vascular

[ Price : $8.95]

FDA warns North Brunswick, NJ-based LeMaitre Vascular about Quality System Regulation and other violations in its manufacturing of...

Allaritys Stenoparib on FDA Fast Track

[ Price : $8.95]

FDA grants fast track designation to Allarity Therapeutics investigational ovarian cancer drug stenoparib.