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

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

Abbott issues urgent correction for FreeStyle Libre 3 Sensors amid safety concerns

Globally, Abbott has received reports of 736 severe adverse events linked to the issue, including seven deaths (none in the US)

Telangana fires up biologics innovation, debuts India's first single-use bioprocess scale-up hub

The State’s PPP model has already mobilised Rs. 150 crore in core infrastructure, while Thermo Fisher has invested Rs. 90 crore in the Bioprocess Design Centre and its co-located Customer Experience Centre

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

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

Solventum to acquire Acera Surgical in $725 million deal

Solventum aims to accelerate innovation in acute wound care, expand its market reach, and deliver enhanced solutions for patients, clinicians, and shareholders

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

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 approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients

The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy