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

Kelun-Biotech’s Sac-TMT shows breakthrough results in first-line lung cancer trial

Sac-TMT is a novel human TROP2 ADC with proprietary intellectual property, targeting advanced solid tumors

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

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

Ind-Swift Laboratories receives certifications from Bureau Veritas

These certifications reflect the company's continuous commitment to maintaining international standards of environmental sustainability as well as occupational health and safety

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels

Contineum MS drug stumbles in mid-stage trial

Topline results from the Phase 2 VISTA trial show that PIPE-307 did not meet its primary or secondary efficacy endpoints

AstraZeneca to invest $2 billion in Maryland manufacturing expansion

The multibillion-dollar Maryland expansion is part of AstraZeneca’s sweeping $50 billion global investment plan

Merck’s two-drug HIV regimen hits phase 3 success

The study successfully met its primary endpoint, demonstrating similar rates of viral suppression for DOR/ISL compared to Biktarvy at 48 weeks

Siolta Therapeutics’ novel microbiome therapy shows promise in preventing allergic diseases in infants