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Ainos Responds to Clinical Hold on Covid Therapy

[ Price : $8.95]

Ainos files a clinical hold response seeking to begin a Phase 2 trial of its low-dose oral interferon (IFN)-alpha formulation Veld...

Glaucoma Pressure Reducer Goes to Panel

[ Price : $8.95]

Federal Register notice: FDA announces a 3/21 advisory committee meeting to discuss a de novo marketing request by Balance Ophthal...

Insight Recalls TING Athletes Foot Spray

[ Price : $8.95]

Insight Pharmaceuticals recalls two lots of its TING 1% Tolnaftate Athletes Foot Spray Antifungal Spray Liquid due to elevated ben...

EUAs Revoked for 2 Covid Tests

[ Price : $8.95]

Federal Register notice: FDA revokes the Emergency Use Authorizations for two Covid-19 tests issued to Southern California Permane...

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Tyra Biosciences Gets Rare Pediatric Designation

[ Price : $8.95]

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