Suneva Medical Inc. inked a merger agreement with Viveon Health On January 12, 2022, Suneva Medical Inc., a leading regenerative aesthetics company, and Viveon Health Acquisition Corp., a particula...
Biogen-Eisai's potential Aduhelm sequel drug secured speedy review by FDA Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been secured a fast-track tag by the FDA, setting up a potentially swift path through the regulatory process. The drug is the next in line behind the pair’s app...
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Aslan Pharmaceuticals enters into a strategic collaboration with IQVIA ASLAN Pharmaceuticals announced the appointment of IQVIA Biotech, a provider of analytics, technology solutions, and clinical research services to the life sciences industry, as its preferred clinical research organisation for log...
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Canon Medical launches super-resolution deep-learning reconstruction for Cardiac CT scans On November 28, 2021, Canon Medical launched the Precise IQ Engine (PIQE) DLR and SilverBeam filter in the recent version of the Aquilion ONE / PRISM edition. PIQE, super-resolution deep-learning reconstruction techno...
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Neurent Medical obtains FDA Clearance for NEUROMARK™, a novel multi-point Nerve Disruption Treatment for Chronic Rhinitis On November 18, 2021, Neurent Medical, a company working in developing treatments for chronic inflammatory sino-nasal diseases, received clearance from the Food and Drug Ad...
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TecTraum’s pro2cool® receives FDA Breakthrough Device Designation for the Concussions treatment On November 03, 2021, TecTraum Inc., working to develop the world’s first point-of-care treatment for concussions, announced that the US Food and Drug Administration (FDA) has provided a Breakthrough Device to its f...
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ReValve Solutions, Inc. declares successful first human use of the Transeptal Mitral Valve Replacement On November 01, 2021, ReValve Solutions, Inc., a company operating in the field of transcatheter structural heart replacement and repair, announced the successful first human use of its transcatheter, Palmetto...
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Progress is driven by innovation. When it comes to developing novel medications and therapeutic biological products, the FDA's Center for Drug Evaluation and Research (CDER) assists the pharmaceutical sector at every stage of the process. CDER offers scientific and regulatory assistance needed to bring innovative m...
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Biogen’s tofersen fails to meet the primary goal in the Phase III ALS trial Biogen has announced that its investigational antisense drug, tofersen (BIIB067), flunked to meet the primary goal of Phase III VALOR clinical trial in superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS) patients. Althou...
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Brickell Plans to Submit New Drug Application to FDA for gel Brickell Biotech will request the FDA in mid-2022 to approve its gel for excessive underarm sweating after decreasing sweat production and disease severity in two pivotal trials. The gel achieved statistical significance in lessening the sever...
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Rheumatoid Arthritis (RA) is a chronic, inflammatory autoimmune disease that leads to progressive an.....
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Alzheimer's disease is an irreversible, progressive disorder of the brain that progressively destroy.....
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A rare autosomal recessive disorder, Familial chylomicronemia syndrome (FCS), affects 1 in 1 to 2 mi.....
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Advances in continuous glucose monitoring (CGM) has led to a paradigm shift in the management of typ.....
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Crohn's disease (CD) is a type of inflammatory bowel disease (IBD). In this condition, the immune sy.....
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Raynaud’s phenomenon (RP) is a condition that results in discoloration of fingers or toes caused b.....
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The American Society of Clinical Oncology (ASCO) is one of the largest and most respected conferences in the field of oncology. Held annually, this conference brings together researchers, physicians, and other healthcare professionals from around the world to discuss the latest advances in cancer research, diagnosis, and treatment.
