Cepheid announced that it has received clearance from the FDA for Xpert BCR-ABL Ultra for monitoring disease burden in patients...
Edwards Lifesciences Corporation announced it has received CE Mark for the SAPIEN 3 Ultra system for transcatheter aortic valve replacement...
Allergan announced that the company has received approval from the FDA to market Juvederm Ultra XC (hyaluronic acid gel) for...
After issuing a recall for the Sapien 3 Ultra delivery system, from Edwards Lifesciences, in July 2019, the FDA now...
Sentynl Therapeutics, Inc./Zydus Lifesciences, Ltd. announced The Medicines and Healthcare products Regulatory Agency (MHRA) authorization of Nulibry (fosdenopterin) for Injection as the first therapy for the treatment of patients in Great Britain (GB) with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants
Edwards Lifesciences Corporation announced that the SAPIEN 3 Ultra system has received FDA approval for transcatheter aortic valve replacement in...
Drug development for ultra-rare diseases is challenging because small sample sizes and heterogeneous study populations hamper the ability of randomized, placebo-controlled trials with a single primary endpoint to demonstrate valid treatment effects.
FUJIFILM VisualSonics Inc., a world leader in ultra high frequency ultrasound imaging systems and subsidiary of FUJIFILM SonoSite, Inc., announced...
Readouts from two phase III clinical trials demonstrated that Eli Lilly and Company's Ultra Rapid Lispro (URLi) met the primary...
Canon Medical Systems USA, Inc.'s newly FDA-cleared Aquilion Precision is the world's first Ultra-High Resolution CT system (UHR CT). The...