FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Approves Mercks Pneumococcal Vaccine

[ Price : $8.95]

FDA approves Mercks Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for preventing invasive disease...

FDA Accepts Aquestive NDA Resubmission

[ Price : $8.95]

FDA accepts for review an Aquestive Therapeutics NDA resubmission for Libervant (diazepam) Buccal Film for managing seizure cluste...

Expanded Use of Prograf Relied on RWE

[ Price : $8.95]

FDA approves a new use for Astellas Pharmas Prograf (tacrolimus), based on real-world, for use in combination with other immunosup...

Shift to Include Pregnant Women in Trials: FDA

[ Price : $8.95]

FDA pushes for a major paradigm shift to move the clinical development community from systemic exclusion to the inclusion of pregn...

Aortic Aneurysm Device is Breakthrough

[ Price : $8.95]

FDA grants Endologix a breakthrough device designation for its ChEVAS (Chimney EndoVascular Aneurysm Sealing) System, an endovascu...

Ardelyx Tenapanor NDA Hits FDA Snag

[ Price : $8.95]

Ardelyx says FDA found deficiencies in the NDA review for tenapanor that preclude discussion of labeling and post-marketing requir...

Nevro OKd for Treating Diabetic Neuropathy

[ Price : $8.95]

FDA approves a Nevro Corp. PMA for its Senza System for treating chronic pain associated with painful diabetic neuropathy.

Latest Federal Register Notices

[ Price : $8.95]

FDA Review posts the Federal Regiter notices for the week ending 7/16/2021.

Panel Shoots Down FibroGens Roxadustat

[ Price : $8.95]

FDAs Cardiovascular and Renal Drugs Advisory Committee votes against recommending approval for a FibroGen NDA for roxadustat, indi...

Guide on Product-specific Bioequivalence

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam....