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Smart Space Shoulder Arthroplasty Planner Cleared

[ Price : $8.95]

FDA clears a LimaCorporate and TechMah Medical 510(k) for the Smart Space Shoulder 3D Planner & 3D Positioner for shoulder arthrop...

Genus Medical Wins Drug/Device FDA Controversy in Court

[ Price : $8.95]

Genus Medical Technologies wins a court decision against FDA to have its contrast agent Vanilla SilQ products regulated as devices...

Sesen Bio Rolling BLA for Bladder Cancer Therapy

[ Price : $8.95]

Sesen Bio begins a rolling BLA for vicinium for treating BCG-unresponsive non-muscle invasive bladder cancer.

Joint Panel to Review Nektar Back Pain Drug

[ Price : $8.95]

Federal Register notice: FDA announces a 1/14/2020 Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and R...

Review Period for Biomarins Palynziq

[ Price : $8.95]

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

Draft Guide on Corticosteroid Products for Hemorrhoids

[ Price : $8.95]

FDA releases a draft guidance entitled Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symp...

Magnetic Resonance Coil Performance Criteria Guide

[ Price : $8.95]

FDA posts a draft guidance on Magnetic Resonance (MR) Coil Performance Criteria for Safety and Performance Based Pathway.

Amgens Remicade Biosimilar Gains Approval

[ Price : $8.95]

FDA approves an Amgen BLA for Avsola (infliximab-axxq), a biosimilar of Janssens Remicade, indicated for treating Crohns disease, ...

Increased Enforcement on Violative Cell/Tissue Products

[ Price : $8.95]

FDA steps up its enforcement efforts against violative cell/tissue products, and issues warnings against Liveyon Labs on the heels...

Physician Convicted in Insy Therapeutics Scheme

[ Price : $8.95]

A federal court convicts New York physician Gordon Freedman for participating in a scheme to receive bribes and kickbacks through ...