FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

ICH M10 Bioanalytical Method Analysis Q&A Guidance

[ Price : $8.95]

FDA publishes an International Council for Harmonization question-and-answer guidance responding to questions about its M10 bioana...

FDA Accelerated Approval for BMS Augtyro Cancer Drug

[ Price : $8.95]

FDA grants accelerated approval to Bristol Myers Squibbs Augtyro to treat some adults and pediatric patients with neurotrophic tyr...

Megadyne Recalls Pediatric Return Electrodes

[ Price : $8.95]

Megadyne recalls its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned du...

Submit Long Covid Drug as IND: FDA

[ Price : $8.95]

FDA says Revive Therapeutics should submit an IND for a clinical trial of its bucillamine as a treatment for Long Covid.

Drug Distribution Security Comment Period Reopened

[ Price : $8.95]

Federal Register notice: FDA reopens the comment period on an 11/20/2023 request for information that is intended to better unders...

Info Collection on Drug Compounding

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Human Drug Compounding, Repackaging, a...

5 Teva ProAir Patents Ordered Out of Orange Book

[ Price : $8.95]

A New Jersey federal judge orders five Teva ProAir patents removed from the FDA Orange Book.

FDA Platform Technology Designation Analyzed

[ Price : $8.95]

Two Morgan Lewis attorneys analyze a recent FDA guidance on how it will implement its drug platform technology designation program...

Positive Results for Setrusumab in Bone Disease

[ Price : $8.95]

Ultragenyx and BioMereo say their setrusumab showed positive results in the Phase 2 portion of the Orbit study in patients with th...

FDA OKs Lillys Retevmo for Some Thyroid Cancers

[ Price : $8.95]

FDA gives traditional approval to Lillys Retevmo for some thyroid cancers in patients aged two and up.