FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Info Collection on OTC Drugs

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Time and Extent Applications (TEA) for Nonpr...

Alpha Cognition NDA for Alzheimers Filed

[ Price : $8.95]

FDA accepts for review an Alpha Cognition NDA for ALPHA-1062 for treating mild-to-moderate Alzheimers disease.

Positive Phase 1/2 Linvoseltamab Results to FDA

[ Price : $8.95]

Regeneron says it will submit a BLA to FDA this year for its linvoseltamab multiple myeloma drug based on successful Phase 1/2 tri...

Pediatric Drug Development Bill Introduced

[ Price : $8.95]

Reps. Eshoo and McCaul introduce bipartisan legislation to strengthen pediatric drug development.

Action Against BPI Methylene Blue Injection Asked

[ Price : $8.95]

Zydus Pharmaceuticals asks FDA to take multiple actions against BPI Labs unapproved methylene blue injection product.

Restrict ANDAs for Generic Xipere: Bausch & Lomb

[ Price : $8.95]

Bausch & Lomb asks FDA to impose conditions on any ANDAs for a generic form of its macular edema drug Xipere.

Guide on Drug Supply Verification Systems

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Verification Systems Under the Drug Supply Chain Security A...

Merck Halts Keytruda Lung Cancer Trial

[ Price : $8.95]

Merck stops a Phase 3 KEYLYNK-008 trial evaluating anti-PD-1 therapy Keytruda (pembrolizumab) in combination with maintenance Lynp...

Regulatory Review Determination for Truseltiq

[ Price : $8.95]

Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for QED Therapeutics Truse...

Pro Publica Slams FDA on Respirator Recall

[ Price : $8.95]

ProPublica and the Pittsburgh Post-Gazette take aim at alleged FDA failures to properly manage a timely response to reports of pro...