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Trax Compression Bone Screws Cleared

[ Price : $8.95]

FDA clears a Trax Surgical 510(k) to market its Trax Compression Screw System that offers a wide range of bone screws for osteotom...

Drug Use Software Guidance Analyzed by Attorneys

[ Price : $8.95]

Foley Hoag attorneys analyze the questions about promotional labeling raised by a recent FDA draft guidance on prescription drug u...

Novartis Touts Positive Lutathera Phase 3 Data

[ Price : $8.95]

Novartis says the Phase 3 NETTER-2 trial met its primary endpoint of improvement in progression-free survival and the key secondar...

FDA Reviewers Dismiss ALS Therapy Benefit

[ Price : $8.95]

FDA reviewers say clinical data submitted in a BrainStorm Cell Therapeutics BLA for Lou Gehrigs Disease treatment NurOwn do not de...

Calcipotriene ANDA Withdrawal Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a 6/2 notice wrongly announcing that Tomers ANDA for calcipotriene was being withdrawn.

FDA Clears Profound Medical Ablation Module

[ Price : $8.95]

FDA clears a Profound Medical 510(k) for the companys Thermal Boost module for use in conjunction with its Tulsa-Pro, which permit...

Exactech Activit-E Polyethylene Cleared

[ Price : $8.95]

FDA clears an Exactech 510(k) for its Activit-E polyethylene for the Vantage Total Ankle System.

VistaPharm Recalls Sucralfate Lot

[ Price : $8.95]

VistaPharm (Largo, FL) recalls one lot of sucralfate oral suspension due to Bacillus cereus contamination.

Coherus Gets Complete Response on Udenyca

[ Price : $8.95]

FDA issues Coherus BioSciences a complete response letter on its BLA supplement for Udenyca Onbody, the companys on-body injector ...

Manufacturing Resumes at Damaged Pfizer Site

[ Price : $8.95]

After suffering severe tornado damage at its Rocky Mount, NC plant, Pfizer says it has now restarted most manufacturing lines.