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

Lupin receives 7 observations from USFDA for Goa manufacturing facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe

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

FDA nod to groundbreaking bladder cancer combo therapy for surgery patients

Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options