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Poseida Orphan Status for CAR-T Cell Therapy

[ Price : $8.95]

FDA grants Poseida Therapeutics an orphan drug designation for its P-BCMA-ALLO1, a novel BCMA-targeted allogeneic, T stem cell mem...

Ortho Trivicta Hip System Cleared

[ Price : $8.95]

FDA clears an Ortho Development 510(k) for its Trivicta Hip System, a triple-taper femoral stem that is intended to facilitate an ...

Medos Recalls Cerebase DA Guide Sheath

[ Price : $8.95]

Johnson & Johnsons Medos International Sarl device unit recalls its Cerebase DA Guide Sheath after receiving an increase in compla...

Notice Corrected on Flowtuss NDA Withdrawal

[ Price : $8.95]

Federal Register notice: FDA corrects a 12/18 notice that announced the withdrawal of a Chartwell RX Sciences NDA for Flowtuss.

Guide on Safety Reporting Standards

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled E2D(R1) Post-Approval Safety Data: Definitions and Standard...

Damning Report on Alzheimer Drug Tests: Article

[ Price : $8.95]

A Science investigative report looks at issues found by FDA in a laboratory analysis of results from trials of Cassavas potential ...

Cassidy Wants Test Regulation Ideas

[ Price : $8.95]

Republican Sen. Bill Cassidy asks interested parties to submit their ideas for congressional action to reform the regulation of cl...

FDA Approves Madrigal Fatty Liver Drug

[ Price : $8.95]

FDA approves a Madrigal Pharmaceuticals NDA for Rezdiffra (resmetirom) for treating adults with noncirrhotic non-alcoholic steatoh...

Post-Approval Safety Data Reporting Guide

[ Price : $8.95]

FDA publishes a draft ICH guidance on post-marketing individual case study reporting.

Advisors to Weigh Imetelstat Benefits, Risks

[ Price : $8.95]

FDA medical reviewers ask the Oncology Drug Advisory Committee to weigh the benefits of the benefits and serious risks of Gerons i...