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MedRhythms Stroke Neurorehabilitation System Cleared

[ Price : $8.95]

FDA clears a MedRhythms 510(k) for InTandem, a neurorehabilitation system to improve walking and ambulation in stroke patients.

EarliTec Autism Second Gen Device Cleared

[ Price : $8.95]

FDA clears an EarliTec Diagnostics 510(k) for the second generation of its EarliPoint Evaluation for Autism Spectrum Disorder in c...

Bill Introduced on Biosimilar Substitutions

[ Price : $8.95]

Senators Mike Lee (R-UT), Ben Ray Lujn (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH) introduce a bill to ease biosimilar interc...

Guide on Cell, Gene Therapy Manufacturing Changes

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Manufacturing Changes and Comparability for Human Cellular ...

Guide on Postmarketing Study Noncompliance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Studies and Clinical Trials: Determining Good...

Veklury Approved for Covid Plus Renal Impairment

[ Price : $8.95]

FDA approves a Gilead Sciences supplemental NDA for the use of Veklury (remdesivir) in Covid-19 patients with severe renal impairm...

Cell, Gene Manufacturing Changes, Comparability

[ Price : $8.95]

FDA publishes a draft guidance on managing manufacturing changes for human cellular and gene therapy products.

Opill Approved as 1st OTC Oral Contraceptive

[ Price : $8.95]

FDA approves a Laboratoire HRA Pharma (recently acquired by Perrigo) NDA to move its contraceptive Opill (norgestrel) tablet from ...

Dr. Reddys Rituxan Biosimilar BLA Accepted

[ Price : $8.95]

FDA accepts for review a Dr. Reddys Laboratories BLA for its proposed biosimilar rituximab (Genentechs Rituxan) candidate.

FDA Guide on Postmarketing Noncompliance Good Cause

[ Price : $8.95]

FDA publishes a draft guidance with information on how it determines good cause for noncompliance with prescription drug section 5...