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Rare Daily Staff Democratic members of the House Committee on Energy and Commerce sent a letter for […]
Read moreFDA Takes First Step Toward International Regulation of Gene Therapies to Treat Rare Diseases
Rare Daily Staff In January, the FDA announced the launch of its Collaboration on Gene Therapies Global […]
Read moreFDA Creates New Advisory Committee of Genetic Metabolic Disease
Rare Daily Staff The U.S. Food and Drug Administration said it is creating a new advisory committee […]
Read moreFDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies
Rare Daily Staff The U.S. Food and Drug Administration announced a pilot program aimed at accelerating the […]
Read moreEuropean Trade Group Warns Proposed Overhaul to Orphan Regulations Decrease Innovation and Hurt Patients
Rare Daily Staff Proposed changes to the European Union’s Orphan Medicinal Product Regulation will reduce investment in […]
Read moreFTC Temporarily Withdraws Challenge to Amgen-Horizon Acquisition in Effort to Settle
Rare Daily Staff The U.S. Federal Trade Commission said it has temporarily withdrawn its administrative complaint of […]
Read moreEMA Approves First Digital Outcome Measure as Primary Endpoint in Pivotal Trials
Rare Daily Staff The European Medicines Agency said that it will accept a digital endpoint for ambulant […]
Read moreFTC Sues to Block Amgen’s $27.8 Billion Acquisition of Horizon
Rare Daily Staff The Federal Trade Commission filed a lawsuit to block Amgen’s acquisition of Horizon Therapeutics, […]
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