FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Indica Labs Digital Pathology Platform Cleared

[ Price : $8.95]

FDA clears an Indica Labs 510(k) for HALO AP Dx, a digital pathology platform that the company says enables slides to be reviewed ...

Animal Drug Regs Amended for Approvals

[ Price : $8.95]

Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for made during January, Fe...

Expiry Dates Extended on CTK Bios Covid Tests

[ Price : $8.95]

FDA says CTK Biotechs ImmuView Covid-19 Antigen Home Test now has a longer shelf life than previously authorized.

Ascendis Pharma NDA Review Extended

[ Price : $8.95]

FDA extends by three months its review of an Ascendis Pharma NDA for TransCon PTH (palopegteriparatide) due to the companys submis...

FDA OKs Expanded Clinolipid Use

[ Price : $8.95]

FDA approves Baxters expanded indication for parenteral (intravenous) nutritient Clinolipid (lipid injectable emulsion) for use in...

Respironics Recall of Trilogy Evo Ventilators

[ Price : $8.95]

Philips Respironics recalls (Class 1) its Trilogy Evo continuous ventilator devices due to a software issue that may cause a power...

Novo Nordisk Filing BLA for Hemophilia A Drug

[ Price : $8.95]

Novo Nordisk says it will seek FDA approval by the end of the year for Mim8, its next-generation Factor 8a mimetic bispecific anti...

Merus Breakthrough Status for Petosemtamab

[ Price : $8.95]

FDA grants Merus a breakthrough therapy designation for petosemtamab for treating certain patients with recurrent or metastatic he...

Warning on Cue Healths Covid Tests

[ Price : $8.95]

FDA issues a warning for healthcare providers and consumers not to use Cue Healths Covid-19 tests due to the increased risk of fal...

Eugia Sent 7-Item 483 After India Inspection

[ Price : $8.95]

FDA issues Eugia Pharma Specialties (an Aurobindo subsidiary) a seven-item Form-483 following a 5/3-concluded inspection at its st...