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Food and Drug Administration

U.S. Food and Drug Administration Approves FoundationOne Liquid CDx as a Companion Diagnostic for Pfizer’s BRAFTOVI in Combination With Cetuximab to Identify Patients With...

Foundation Medicine Inc., announced that it has received approval from the U.S. Food and Drug Administration for FoundationOne Liquid CDx to be used as...

Penumbra Expands Computer-Aided Thrombectomy Offerings with Lightning Bolt 7 Technology Designed to Rapidly Remove Blood Clots with Modulated Aspiration

Penumbra, Inc, a global healthcare company focused on innovative therapies, announced the U.S. Food and Drug Administration (FDA) clearance and launch of Lightning Bolt™ 7,...

Alzheimer’s Association Statement on CMS Announcement of Registry for Access to FDA-Approved Alzheimer’s Treatments

The Alzheimer's Association recognizes that the Centers for Medicare & Medicaid Services (CMS) has announced their conceptual approach to fulfill their commitment to immediate...

Cure Rare Disease Receives Muscular Dystrophy Association Grant

Cure Rare Disease, a clinical-stage nonprofit biotechnology company, has been awarded an advocacy collaboration grant from the Muscular Dystrophy Association (MDA) to support research on novel...

FDA Proposes Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities

As the oldest comprehensive consumer protection agency in the country, for more than a century the U.S. Food and Drug Administration has been responsible...
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