FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Globus Gets HDE for Scoliosis Corrector

[ Price : $8.95]

FDA grants Globus Medical a humanitarian device exemption to allow the marketing of the Reflect Scoliosis Correction System.

Onpattros Regulatory Review Period Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alnylam Pharmaceuticals Onp...

Byondis BLA on Breast Cancer Therapy Rejected

[ Price : $8.95]

FDA issues Byondis a complete response letter on its BLA for SYD985 ([Vic-] trastuzumab duocarmazine) for use in patients with HER...

Supreme Court Turns Down Skinny Label Case

[ Price : $8.95]

The U.S. Supreme court decides to not hear a closely watched appeal of a lower courts ruling in a so-called skinny label case won ...

Panel Backs Epinephrine Nasal Spray

[ Price : $8.95]

FDAs Pulmonary-Allergy Drug Advisory Committee votes to recommend approval for ARS Pharmaceuticals neffy (epinephrine) nasal spray...

Final Withdrawal Decision on Makena Published

[ Price : $8.95]

Federal Register notice: FDA publishes its final decision rendered last month to withdraw approval of Covis Pharma Groups Makena (...

Guide on Blood Product Donor Eligibility

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Recommendations for Evaluating Donor Eligibility Using Indi...

18 Drugs Not Withdrawn Due to Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that 18 drug products listed in the notice were not withdrawn from sale due to safety or e...

Orphan Status for Pyxis Pancreatic Cancer Therapy

[ Price : $8.95]

FDA grants Pyxis Oncology an orphan drug designation for PYX-201 in pancreatic cancer.

Cordis Class 1 Recall of Angioguard System

[ Price : $8.95]

Rated Class 1 by FDA, Cordis recalls its Angioguard RX/XP Emboli Capture Guidewire System due to device separation concerns.