SPARC announces receipt of priority review voucher associated with Sezaby approval

A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases

Sanofi’s Venglustat shows breakthrough results in rare neurological Gaucher disease

Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs

Lupin launches Dasatinib tablets in US, eyes $930 million oncology market

EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C

The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients

Novo Medi Sciences unveils India’s next-generation varicella vaccine NEXIPOX PLUS

This innovation enhances viral stability, preserves potency, and reduces allergic reactions and antigen crystallisation-related issues

Teva’s AJOVY gains spotlight as first preventive migraine treatment for kids

The findings, from the SPACE study, paved the way for FDA approval of AJOVY for pediatric patients aged 6-17 years weighing 45 kilograms

Bristol Myers Squibb reports positive Phase 3 results for Camzyos in adolescents with oHCM

The study showed a statistically significant reduction in Valsalva left ventricular outflow tract (LVOT) gradient at Week 28 compared with placebo

GRIN Therapeutics launches global Phase 3 trial for groundbreaking GRIN-NDD therapy

GRIN-NDD is one of the most complex neurodevelopmental disorders with limited treatment options today

Rapid-acting ADHD treatment Azstarys now approved in China

ADHD is a common, chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood

FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA

The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement