FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Alzheimers Assay Gets Breakthrough Designation

[ Price : $8.95]

FDA grants Beckman Coulter Diagnostics a breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 plasma ...

Enhertu Approval Broadens Breast Cancer Use

[ Price : $8.95]

FDA approves AstraZeneca and Daiichi Sankyos Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or met...

No Informed Consent at Trial Site: FDA

[ Price : $8.95]

FDA warns the Miami Dade Medical Research Institute and Dr. Americo Padilla about failing to obtain proper informed consent for pe...

2 Firms Illegally Selling Biologics: FDA

[ Price : $8.95]

FDA warns New York, NY-based Evolutionary Biologics and Chatsworth, CA-based Chara Biologics about illegally manufacturing and dis...

FDA Priority Review for New Merck Welireg Indication

[ Price : $8.95]

FDA sets 5/25 for its decision on a new indication for Mercks Welireg to treat patients with advanced pheochromocytoma and paragan...

AI Optics Handheld Retinal Imager Cleared

[ Price : $8.95]

FDA clears an AI Optics 510(k) for its Sentinel Camera, a handheld retinal imaging device for capturing images of the human eye.

TerSera Wants Prialt ANDA Conditions

[ Price : $8.95]

TerSera petitions FDA to require any ANDA referencing Prialt to conduct compatibility testing with the Medtronic pump that is spec...

RFK Jr.s Cousin Trashes Him on Eve of Hearing

[ Price : $8.95]

Robert F. Kennedy Jr.s cousin, Caroline Kennedy, sends a scathing letter about his background to U.S. senators on the eve of a con...

Provepharm Recalls Phenylephrine HCl

[ Price : $8.95]

Provepharm recalls one lot of phenylephrine hydrochloride injection, USP, 10 mg/mL due to a customer complaint about visible black...

Once Monthly Leqembi for Alzheimers Approved

[ Price : $8.95]

FDA approves an Eisai/Biogen supplemental BLA for Leqembi (lecanemab-irmb) and its intravenous use once every four weeks as mainte...