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Senate Gives FDA $170 Million Boost for FY 2025

[ Price : $8.95]

The Senate Appropriations Committee marks up and approves FDAs fiscal year (FY) 2025 budget, providing a $170 million (2.5%) boost...

Payers Should Help in Evidence Generation: Report

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FDA researchers stress the need for more payer involvement in evidence generation to support clinical practice following drug appr...

Arcutis Biotherapeutics Zoryve OKd for Atopic Dermatitis

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FDA approves an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) cream, 0.15%, for treating mild to moderate atop...

Regenerative Medicine Designation for Alzheimers Therapy

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FDA grants Longeveron a Regenerative Medicine Advanced Therapy designation for Lomecel-B and its use for treating mild Alzheimers ...

Opioid Treatment Devices Study Guidance

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FDA publishes a guidance recommending principles for use in pivotal clinical studies to demonstrate the safety and effectiveness o...

Kazia Touts Glioblastoma Drug Trial Results

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Kazia Therapeutics says it will meet with FDA about a potential accelerated approval pathway for its glioblastoma drug paxalisib f...

Workshop on AI in Drug/Biologic Development

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Federal Register notice: FDA announces an 8/6 public workshop entitled Artificial Intelligence (AI) in Drug & Biological Product D...

Panel to Review Niemann-Pick Disease NDA

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Federal Register: FDA schedules an 8/2 advisory committee meeting to discuss a Zevra Denmark A/S NDA for arimoclomol, indicated fo...

FDA Clears ImmersiveAR for OR Use

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FDA clears ImmersiveTouchs ImmersiveAR virtual and augmented reality operating room platform.

CBER Staff Guide on IND Processing, Review

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CBER issues a standard operating policy and procedure staff guide on administrative processing and review management procedures fo...