FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Marks 50th Anniversary of Device Amendments

[ Price : $8.95]

FDA marks the 50th anniversary of the 1976 Medical Device Amendments by highlighting the laws lasting role in shaping the modern o...

FDA Updates Phillips Trilogy Ventilator Corrections

[ Price : $8.95]

FDA issues an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that ...

Berens Infantile Niemann-Pick disease Drug Review Extended

[ Price : $8.95]

FDA extends by three months its review timeline of a Beren Therapeutics NDA for adrabetadex for treating infantile-onset Niemann-P...

Imfinzi Get Expanded Use in High-Risk Bladder Cancer

[ Price : $8.95]

FDA approves AstraZenecas Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-nav...

Pitts Named to BrainStorm Cell Therapeutics Board

[ Price : $8.95]

BrainStorm Cell Therapeutics names former FDA associate commissioner Peter Pitts to its board of directors.

Panel Recommends Dominant Covid Variant for Upcoming Vaccines

[ Price : $8.95]

An FDA advisory committee recommends updating Covid-19 vaccines for the 2026-2027 immunization season to target the currently domi...

CGMP Violations in GC America Inspection

[ Price : $8.95]

FDA warns Alsip, IL-based GC America about CGMP violations in its production of finished drugs.

AstraZeneca Breast Cancer NDA Review Extended by FDA

[ Price : $8.95]

FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional ...

Corcept Plans Resubmission of Cushings NDA

[ Price : $8.95]

Corcept Therapeutics plans to resubmit its NDA for relacorilant as a treatment for patients with Cushings syndrome, following addi...

AbbVies NDA for Dendritic Cell Neoplasms Approved

[ Price : $8.95]

FDA approves an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy) and its use in treating adults with blastic plasmacytoid dendrit...