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Advisors Surveyed on Committee Reforms

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3D Communications shares the results from its survey of FDA advisory committee members on committee reform issues.

Surgical Plannings New HipInsight Cleared

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FDA clears a Surgical Planning Associates 510(k) for its new HipInsight 2.0 mixed-reality guidance system for hip arthroplasty.

Clinical Hold Removed on Dravet Syndrome Drug

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FDA removes a partial clinical hold on Stoke Therapeutics zorevunersen (STK-001) and its use in children and adolescents with Drav...

FDA Clears BioVie for Parkinsons Trial

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FDA gives BioVie the go-ahead to begin its Phase 2 SUNRISE-PD trial in Parkinsons disease patients.

Abiomed Recalls Impella CP Heart Pumps

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Abiomed recalls (Class 1) certain Impella CP with SmartAssist heart pumps after nine devices in a single lot failed inspection.

Kyverna Gets FDA Regenerative Medicine Status

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FDA awards Kyverna Therapeutics a regenerative medicine advanced therapy designation for the companys CAR T-cell product candidate...

Panel to Discuss Ocaliva Confirmatory Data

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Federal Register notice: FDA announces a 9/13 advisory committee meeting to discuss an Intercept Pharmaceuticals supplemental NDA ...

Meeting on New Rare Disease Therapies Hub

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Federal Register notice: FDA announces a 10/16 public meeting entitled Advancing Rare Disease Therapies Through an FDA Rare Diseas...

FDA Withdraws Plans on Kratom/Psychedelics Research

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Federal Register notice: FDA withdraws an 8/2 notice that sought comments on a proposed information collection entitled Risk/Safet...

Lykos to Appeal MDMA Drug Rejection

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After receiving a complete response letter, Lykos Therapeutics says it will pursue FDAs dispute resolution process to question the...