FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Orders Stricter Safety Labeling for Skysona

[ Price : $8.95]

FDA orders significant labeling changes for Bluebird Bios Skysona (elivaldogene autotemcel), a gene therapy approved for treating ...

Sodium Chloride Drug Shortage Resolved: Makary

[ Price : $8.95]

FDA says a nationwide shortage of sodium chloride 0.9% injection products has officially ended.

BD Recalls BD Alaris Pump Software

[ Price : $8.95]

Becton Dickinson recalls (Class 1 device correction) its BD Alaris Pump Module Model 8100 with Guardrails, Suite MX software versi...

Accelerated OK for Boehringer Lung Cancer Drug

[ Price : $8.95]

FDA grants Boehringer Ingelheim accelerated approval for Hernexeos (zongertinib), a kinase inhibitor for treating certain adults w...

FDA Ramps Up Global Drug Quality Oversight

[ Price : $8.95]

FDA expands its drug quality enforcement efforts since the end of the Covid-19 Public Health Emergency, with foreign oversight rea...

FDA Acting Against Unapproved Thyroid Meds

[ Price : $8.95]

FDA says it will allow up to 12 months for doctors to transition patients who are taking unapproved animal-derived thyroid medicat...

Lilly Plans NDA for Oral Weight-Loss Drug

[ Price : $8.95]

Eli Lilly says it will file an NDA by the end of the year for its investigational obesity treatment orforglipron, based on just-an...

Valneva Chikungunya OK to Use Again: FDA

[ Price : $8.95]

FDA lifts an earlier recommended pause on the use of Valnevas Ixchiq vaccine for chikungunya virus.

FDA Steps to Boost U.S. Drug Production

[ Price : $8.95]

FDA says it is starting the FDA PreCheck program to help drug companies develop manufacturing facilities in the U.S.

ICH Extractables, Leachables Guide

[ Price : $8.95]

FDA publishes a draft International Council on Harmonization guideline for extractables and leachables to solicit public comment.