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Cardinal Health Recalls Urology/Operating Trays

[ Price : $8.95]

Due to an earlier Nurse Assist, LLC product recall, Cardinal Health is recalling products supplied to it for use in Covidien and C...

Vertex Plans Mid-year Cystic Fibrosis NDA

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Vertex Pharmaceuticals plans to file an NDA by mid-year and use a priority review voucher for its cystic fibrosis combination drug...

Rep. Waltz Questions FDAs Telework Policy

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Congressman Mike Waltz (R-FL) asks FDA for clarification on the agencys telework policies which have minimized the operational sta...

Hologics Cervical Cancer Diagnostic Cleared

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FDA clears a Hologic 510(k) for its Genius Digital Diagnostics System with the Genius Cervical AI algorithm, a digital cytology sy...

Edwards Tricuspid Valve Replacement Approved

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FDA approves Edwards Lifesciences Evoque tricuspid valve replacement system for treating tricuspid regurgitation.

Tyra Biosciences Gets Rare Pediatric Designation

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FDA grants Tyra Biosciences a rare pediatric disease designation for TYRA-300, an oral FGFR3 selective inhibitor for treating acho...

Cardinal Health Recalls Monoject Syringes

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Cardinal Health recalls all sizes of its Monoject sterile Syringe Luer-Lock Tip Soft Packs and Monoject sterile Enteral Syringes w...

Benefits/Challenges of Decentralized Trials: Commentary

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A new online commentary by two CDER Office of Medical Policy officials outlines the advantages and challenges of conducting decent...

Panel to Review Carvykti and Abecma sBLAs

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Federal Register notice: FDA announces a 3/15 Oncologic Drugs Advisory Committee meeting to discuss sBLAs for Janssens Carvykti an...

7 ex-FDA Commissioners Weigh In on Mifepristone

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Seven former FDA commissioners file an amicus brief with the Supreme Court urging that a lower court ruling restricting access to ...