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Emergency Use for Device to Wean Ventilator Use

[ Price : $8.95]

FDA grants an emergency use authorization for Synapse Biomedical and its TransAeris Diaphragmatic Pacing Stimulator System to free...

ICH Pediatric Guideline at Step 4

[ Price : $8.95]

The ICH says its S11 guideline on safety testing supporting pediatric drug development has reached Step 4 of the approval process.

Info Collection for Committee Member Nominations

[ Price : $8.95]

Federal Register notice: FDA sends to OMB a proposed information collection entitled FDA Advisory Committee Membership Nominations...

Website Warned on Covid-19 Unapproved Drugs

[ Price : $8.95]

FDA warns a Web site that it is selling unapproved and misbranded new drugs as a treatment for Covid-19.

FDA Approves Urothelial Cancer Therapy

[ Price : $8.95]

FDA approves a UroGen Pharma NDA for Jelmyto (mitomycin gel), indicated for treating low-grade upper tract urothelial cancer.

FDA Grants Emergency Use for 2 Antibody Tests

[ Price : $8.95]

FDA grants emergency use authorizations to two Covid-19 antibody tests.

Viveve Resubmits Urinary Incontinence Trial IDE

[ Price : $8.95]

Viveve Medical says it has resubmitted an IDE to FDA for approval to conduct the PURSUIT trial of its CMRF treatment for stress ur...

Comments on Competitive Biosimilar Marketplace Workshop

[ Price : $8.95]

Five drug stakeholders comment on a recent FDA/FTC workshop on building a competitive marketplace for biosimilars.

Info Collection on Safety Communication Survey Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws a 3/6 Federal Register notice on a proposed information collection entitled Food and Drug A...

RemeGen Gets Fast Track for Lupus Drug

[ Price : $8.95]

FDA grants RemeGen a fast track designation for RC18, a novel recombinant TACI-Fc fusion protein for treating systemic lupus eryth...