New Drug Application

NASH is a progressive disease of the liver and a significant unmet medical need. There are currently no treatments available for…

Alembic said it has a cumulative total of 104 abbreviated new drug application (ANDA) approvals from USFDA

As per the USFDA, a Complete Response Letter (CRL) is sent to an applicant if the agency determines that it will not approve the…

SPARC had earlier received a final approval from US FDA in March 2015 for this product Sun Pharma Advanced Research Company…