FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

ICH M12 Drug Interaction Guideline Out

[ Price : $8.95]

The International Council on Harmonization publishes the M12 final guideline on drug interactions and an accompanying question-and...

Anzures-Camarena Debarred Over Counterfeits

[ Price : $8.95]

Federal Register notice: FDA issues an order permanently debarring Maria Anzures-Camarena from providing services related to an ap...

3 No-Longer-Marketed NDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws three NDAs from multiple applicants after they notified the agency that the products were n...

FDA Oks Amgens Bkemv as Soliris Biosimilar

[ Price : $8.95]

FDA approves Amgens Bkemv as an interchangeable biosimilar for Alexions Soliris, indicated to treat two rare diseases.

J&J Reports Positive Depression Drug Data

[ Price : $8.95]

Johnson & Johnson reports positive topline results from its pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and saf...

Lab Association Sues FDA Over LDT Rule

[ Price : $8.95]

The American Clinical Laboratory Association and HealthTrackRX sue FDA to block the agencys final rule asserting authority over la...

FDA OKs Retevmo for Pediatric Thyroid Cancer

[ Price : $8.95]

FDA grants Eli Lilly accelerated approval for Retevmo (selpercatinib) for pediatric patients two years of age and older with advan...

Info Collection on Device De Novo Requests

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an OMB information collection extension entitled De Novo Classification Process (Ev...

Invivyds Pemgarda Gets EUA for Covid

[ Price : $8.95]

Federal Register notice: FDA announces the issuance of an emergency use authorization for Invivyds Pemgarda (pemivibart) for use a...

Ostar Beauty Selling Unapproved Medical Devices: FDA

[ Price : $8.95]

FDA warns Chinas Ostar Beauty Sci-Tech about illegally marketing unapproved medical devices.