Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay

The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026

a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system

Abdomen-pelvis CT is the nation’s highest-volume CT category

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

SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine

The approval by the US FDA comes after extensive safety testing and manufacturing improvements

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

FDA nod to AstraZeneca’s Imfinzi plus FLOT chemotherapy for early and locally advanced gastric cancer

FDA updates label for Sun Pharma’s UNLOXCYT, highlighting durable responses in advanced skin cancer

The update reflects long-term clinical trial data showing that many patients with mCSCC or laCSCC experienced lasting responses

Glenmark Pharma gets VAI from FDA for Monroe facility

The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site

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

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

Zydus receives FDA’s tentative approval for Empagliflozin and Linagliptin tablets