Drug Approval | December 16, 2025
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
The said certificate is valid for a period of 3 years and opens up the European and other markets for the company's products
Dr Srivastava was selected by an expert jury in recognition of her sustained contributions to renewable chemicals, industrial biotechnology and bioprocess innovation
The drug is currently being evaluated in two fully recruited global Phase 3 studies for progressive and tophaceous gout, with results expected in 2026.
Clinical trial enrollment has long been a bottleneck in drug development
The plant can reach an annual capacity of 300 crore tablets and 90 crore capsules
More than five drug candidates from his team progressed to human trials including drugs like Rilematovir (Phase IIb), and Bedaquiline
The inspection concluded with one minor observation in Form 483
Subscribe To Our Newsletter & Stay Updated
