A Prescription Drug User Fee Act target date of June 30, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under ...

The stock price of Zydus Lifesciences surged over 5 per cent in the Tuesday trading session after the drugmaker’s wholly owned subsidiary, Sentynl Therapeutics, received U.S. Food and Drug ...

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A. Multi-Manager ICVC sold 0.52% stake in the company at an average price of Rs ...

One Mobikwik Systems, GM Breweries, Darshan Orna, Kore Foods Krishna Ventures, Leel Electricals, UH Zaveri, and VR Woodart will announce their quarterly earnings on January 7. Recruitment ...

Sentynl took over the therapy’s development and commercialisation from Fortress Biotech's subsidiary Cyprium Therapeutics.

The therapy would be the first treatment for Menkes disease, a rare, fatal pediatric disorder caused by mutations in the copper transporter gene ATP7A. The application has been granted Priority Review ...

CUTX-101 is intended to treat Menkes disease. Credit: luchschenF / Shutterstock. The US Food and Drug Administration (FDA) has accepted for filing and priority review of the new drug application (NDA) ...

1 MRC Centre for Neuromuscular Diseases, UCL Institute of Neurology, London, UK 2 The Graham Watts Laboratories for Research into Motor Neuron Disease, Sobell Department of Motor Neuroscience and ...