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Tempus Receives U.S. FDA Approval for xT CDx, a NGS-Based In Vitro Diagnostic Device

Tempus today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s first Premarket Approval (PMA) application for its companion diagnostic test, xT CDx . xT CDx is a 648-gene next-generation sequencing test for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients.

Tempus Receives U.S. FDA Approval for xT CDx, a NGS-Based In Vitro Diagnostic Device Read More »

Horizon Therapeutics plc Announces Initiation of Phase 3 Clinical Trial in Japan Evaluating TEPEZZA® (teprotumumab-trbw) in Adults with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED)

Horizon Therapeutics plc Announces Initiation of Phase 3 Clinical Trial in Japan Evaluating TEPEZZA ® (teprotumumab-trbw) in Adults with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED).

Horizon Therapeutics plc Announces Initiation of Phase 3 Clinical Trial in Japan Evaluating TEPEZZA® (teprotumumab-trbw) in Adults with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED) Read More »

Maze Therapeutics Announces Exclusive Worldwide License Agreement with Sanofi for MZE001, an Oral Substrate Reduction Therapy for the Treatment of Pompe Disease

Maze Therapeutics announced the signing of an exclusive worldwide license agreement with Sanofi for Maze’s glycogen synthase 1 program, including clinical candidate MZE001, which is currently in development for the treatment of Pompe disease and other potential indications.

Maze Therapeutics Announces Exclusive Worldwide License Agreement with Sanofi for MZE001, an Oral Substrate Reduction Therapy for the Treatment of Pompe Disease Read More »

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