Transmural Systems wins breakthrough FDA nod for coronary-saving TAVR device

The clearance for TELLTALE positions Transmural Systems at the forefront of next-generation electrosurgical solutions for structural heart interventions

Novo Nordisk fast-tracks higher-dose obesity drug to FDA

The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway

Enlivex reports promising six-month data for Allocetra in knee osteoarthritis

Call it a ray of hope for those enduring the pain of knee osteoarthritis -- the most common form of arthritis, affecting over 300 million people worldwide

Cidara hits target enrollment for Phase 3 flu trial ahead of peak season

CD388 is administered as a single 450-milligram subcutaneous dose in adults and adolescents

EU greenlights Dupixent for chronic urticaria, offering new hope to patients

It's a development that marks a major step forward for patients struggling with moderate-to-severe chronic spontaneous urticaria

Otsuka files FDA application for first-in-class ADHD drug

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor

Novo Nordisk’s new diabetes combo drug delivers big wins in mid-stage trial

The trial tested six injectable doses and three oral doses over as long as 36 weeks

Novartis scores FDA nod for game-changing SMA treatment

Itvisma is a one-time, fixed-dose therapy designed to tackle the genetic root cause of SMA

Novo Nordisk’s Semaglutide fails to slow Alzheimer’s progression in Phase 3 trials

The trials, designed to assess whether semaglutide could slow cognitive decline, showed no significant difference compared to placebo in the progression of Alzheimer’s disease over two years

Merck KGaA’s Cladribine capsules gain FDA fast track for rare neuromuscular disorder