FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
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
This launch is part of the company's strategy to expand its nutraceutical portfolio
The reform is set to modernise how medicines are developed, authorised, and made available across the EU
Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia
The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste
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
Subscribe To Our Newsletter & Stay Updated