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

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

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

Zydus receives FDA’s final approval for Verapamil Hydrochloride ER tablets