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Magnetic Resonance Coil Performance Criteria Guide

[ Price : $8.95]

Federal Register notice: FDA releases a draft guidance on Magnetic Resonance (MR) Coil Performance Criteria for Safety and Perfor...

House Bill Introduced to Lower Drug Costs

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Republican House lawmakers introduce the Lower Costs, More Cures Act (H.R. 19) to lower drug costs for Americans without limiting ...

Equillium Gets Fast Track for Itolizumab

[ Price : $8.95]

FDA grants Equillium a fast track designation for itolizumab for treating lupus nephritis.

Draft Guidance Hemorrhoid Drugs

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Development of Locally Applied Corticosteroid Products for ...

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

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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

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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

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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

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

Draft Guide on Corticosteroid Products for Hemorrhoids

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FDA releases a draft guidance entitled Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symp...