FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Court Orders FDA to Reconsider Vanda sNDA

[ Price : $8.95]

An appeals court rules that FDA improperly rejected Vanda Pharmaceuticals request for a hearing on its supplemental NDA for sleep ...

Advisory Panel Conflicts of Interest Low: Study

[ Price : $8.95]

A new study in JAMA finds that conflicts of interest among federal vaccine advisors had fallen to historic lows well before HHS se...

Tandem Recalls Insulin Pumps Due to Alarm Error

[ Price : $8.95]

Tandem Diabetes Care recalls (Class 1 device correction) certain t:slim X2 insulin pumps to address a potential speaker-related is...

Workshop on Patient Experience Data in Drug Development

[ Price : $8.95]

FDA announces a two-day virtual public workshop to address methodological challenges in using patient experience data in drug deve...

Wegovoy OKd for Metabolic Steatohepatitis

[ Price : $8.95]

FDA grants Novo Nordisk accelerated approval for a new Wegovy (semaglutide) indication for treating metabolic dysfunction-associat...

FDA OKs Tonix Drug for Fibromyalgia

[ Price : $8.95]

Tonix Pharmaceuticals gains approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a once-daily, non-opioid drug for treati...

FDA Delays Clinical Hold Review on Neurizon ALS Drug

[ Price : $8.95]

Staffing cuts and other administrative disorders leads to a review extension on a clinical hold review on Neurizon Therapeutics N...

FDA Alert on Baxter Novum Infusion Pumps

[ Price : $8.95]

FDA issues an alert on all Baxter Novum IQ Large Volume Pumps and Novum IQ Syringe Pumps after becoming aware of a company notific...

Omeros BLA for Narsoplimab Gets Review Extension

[ Price : $8.95]

FDA extends by three months its review of an Omeros resubmitted BLA for narsoplimab in hematopoietic stem cell transplant-associat...

FDA OKs Papzimeos for Respiratory Papillomatosis

[ Price : $8.95]

FDA approves a Precigen BLA for Papzimeos (zopapogene imadenovec-drba), a non-replicating adenoviral vector-based immunotherapy fo...