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BlackSwan Vascular PMA for Arterial Hemorrhage OKd

[ Price : $8.95]

FDA approves a BlackSwan Vascular PMA for its Lava Liquid Embolic System for treating peripheral arterial hemorrhage.

Intarcia Raises NDA Advisory Committee Issues

[ Price : $8.95]

Hogan Lovells attorney David Fox says Intarcia has several concerns about the fairness of an advisory committee meeting that the c...

Workshop on Rare Disease Endoints

[ Price : $8.95]

Federal Register notice: FDA announces a 6/7-8 public workshop entitled Rare Disease Endpoint Advancement Pilot Program Workshop: ...

Cue Health EUA for Mpox Molecular Test

[ Price : $8.95]

Federal Register notice: FDA announces the issuance of an emergency use authorization to Cue Health for the Cue Mpox (Monkeypox) M...

Panel Backs Rexulti for Alzheimers Agitation

[ Price : $8.95]

A joint advisory committee meeting votes 9 to 1 that an Otsuka Pharmaceutical and Lundbeck a sNDA for Rexulti (brexpriprazole) pro...

FDA Clears Reader for FreeStyle Libre 3

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FDA clears an Abbott 510(k) for a reader for its FreeStyle Libre 3 integrated continuous glucose monitoring system.

Avenue Therapeutics Plans IV Tramadol Resubmission

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Avenue Therapeutics meets with FDA to map out a plan for resubmitting a twice-rejected NDA for intravenous tramadol for treating p...

GSK Plans NDA for Antibiotic Gepotidacin

[ Price : $8.95]

GSK says it will submit an NDA by 6/30 for antibiotic gepotidacin and its use in treating uncomplicated urinary tract infections.

FDA Top Cop McMeekin Retiring 6/30, Then Many More

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FDA associate commissioner for regulatory affairs Judith McMeekin announces her retirement after 15 years at the agency, observing...

Gamida Cell Therapy Approved by FDA

[ Price : $8.95]

FDA approves a Gamida Cell Ltd. BLA for Omisirge (omidubicel-onlv), a modified allogeneic cord blood-based cell therapy to speed r...