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Medical Devices

Medtronic Files PMA for Hugo Urology Surgical Robot

Medtronic files a PMA for its Hugo robotic-assisted surgery system for a urologic indication.

FDA General

BlackfinBio Plans Gene Therapy Trial

FDA clears BlackfinBio to conduct a Phase 1/2 clinical trial of its novel adeno-associated virus gene therapy, BFB-101, in children with hereditary sp...

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Human Drugs

FDA Turns Down Telix Glioma Imaging Agent

FDA issues Telix Pharmaceuticals a complete response letter on its NDA for Pixclara (floretyrosine F18), a positron emission tomography agent for imag...

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Human Drugs

FDA Clinical Hold on VYNEs Psoriasis Drug

FDA issues a clinical hold on VYNE Therapeutics Phase 1b study evaluating VYN202 for treating moderate-to-severe plaque psoriasis based on testicular ...

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FDA General

RFK Jr. Restoring FDAs Freedom of Information Office

HHS secretary Robert F. Kennedy Jr. vows to restore FDAs and other health agencies Freedom of Information Act (FOIA) offices that were gutted earlier ...

Medical Devices

Breakthrough Status for Blood Pressure Therapy

FDA grants Orchestra BioMed a breakthrough device designation for its atrioventricular interval modulation therapy that uses a pacemaker to reduce blo...

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Human Drugs

Texas Court Gives FDA Win in Compounding Enforcement

A Northern Texas federal judge denies a preliminary injunction sought by Outsourcing Facilities Association to delay FDA enforcement actions against c...

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Human Drugs

An FDA Reviewer Exodus on the Horizon: Gottlieb

Former FDA commissioner Scott Gottlieb says FDA is likely to see up to a 25% reviewer exodus over the coming months as about 600 reviewers have curren...

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Biologics

One-Third of Biosimilars Approved Not Launched: Report

A new biosimilars report says that FDA has approved a total of 73 biosimilars across 19 unique biological molecules, and so far only 48 (66%) of these...

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Human Drugs

Staff Cuts Lead to Drug Data Gaps: Sources

Axios reports that key FDA databases that are relied on by healthcare professionals are not being fully updated due to staff shortages resulting from ...