FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Intellia Rolling BLA for Hereditary Angioedema CRISPR Therapy

[ Price : $8.95]

Intellia Therapeutics starts a rolling BLA submission for its experimental gene-editing therapy lonvoguran ziclumeran, or lonvo-z,...

FDA Cites Sterile Processing, QC at Outsourcing Facility

[ Price : $8.95]

FDA identifies significant deficiencies at BayCare Integrated Service Center, an outsourcing facility in Temple Terrace, FL, follo...

Priority Review for Jazzs Zanidatamab Combo for Gastric Cancer

[ Price : $8.95]

FDA accepts for priority review a Jazz Pharmaceuticals supplemental BLA for Ziihera (zanidatamab-hrii) for use in combination regi...

Judge Dismisses Homeopathy Industry Challenge to FDA Policy Shift

[ Price : $8.95]

A federal judge dismisses a lawsuit brought by homeopathy advocates and a product distributor challenging FDAs decision to tighten...

Political Pressure on Psychedelics May Undermine FDA Approvals: Experts

[ Price : $8.95]

Concerns that political pressure could undermine the U.S. drug approval system intensify this week after a new White House directi...

FDA Set to Outline Major Steps Toward Real-Time Clinical Trials

[ Price : $8.95]

FDA plans to unveil a significant shift in how clinical trials are conducted and regulated, announcing major steps to implement re...

Galaxy Therapeutics Completes FDA Filing for Aneurysm Device

[ Price : $8.95]

Galaxy Therapeutics has submitted the final module of a PMA for its SEAL device, a treatment designed for patients with wide-neck ...

FDA Compliance Office Ramped Up Enforcement in 2025

[ Price : $8.95]

CDER's Office of Compliance releases a new annual report showing that it expanded enforcement and oversight activities in 2025.

Lonza Cited Over Manufacturing, Quality Control at Swiss Plant

[ Price : $8.95]

FDA raises multiple manufacturing and quality control concerns at a Swiss drug substance facility operated by Lonza Group, followi...

FDA Announces Moves to Fast-Track Psychedelic Therapies

[ Price : $8.95]

FDA announces several actions aimed at accelerating the development of treatments for serious mental illness, following a recent e...